Clinical trial NCT00503698: The Effect of Somatropin Treatment in Adult Patients on Chronic Dialysis
Official title: Efficacy and Safety of Somatropin in Adult Patients on Chronic Haemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Disease
End-Stage Renal Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-07-19
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.

The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.

Detailed description: The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.

Eligibility criteria: Inclusion Criteria:

* Serum albumin as specified in protocol
* Malnourished (based on serum albumin value below 40 g/L, assessed centrally)
* Stable (for 3 months or more) and adequate haemodialysis treatment three months prior to enrolment as defined by Kt/V of more than 1.2

Exclusion Criteria:

* Active malignant disease
* Critical illness requiring treatment in an intensive care unit (ICU)
* Uncontrolled treated/untreated hypertension
* Patients on chronic (more than 3 months) treatment with steroids in doses of more than 10 mg/day prednisolone (or equivalent)
* Patients treated with immunosuppressive agents
* Known Growth Hormone Deficiency
* Patients suffering from any clinically significant disease history in the opinion of the investigator
* Severe illness as defined in the protocol (as judged by the investigator)

Primary outcomes:
measure: Mortality - Time to All-cause Death
timeFrame: week 0, trial termination
Secondary outcomes:
measure: Morbidity - Time From Randomisation to Next Cardiovascular Event (Defined as Composite of All-cause Mortality, Non-fatal Myocardial Infarction, Stroke, Cardiac Insufficiency and Other Thrombo-embolic Event)
timeFrame: week 0, trial termination
measure: Morbidity - Number of Hospitalisations, in Addition to Normal Dialysis Procedures
timeFrame: week 0, trial termination
measure: Mortality - Two-year Mortality Rate
timeFrame: week 0, trial termination
measure: Health Related Quality of Life Assessments
timeFrame: week 0, trial termination
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Madison
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Tuscon
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facility: Novo Nordisk Investigational Site
state: Arizona
city: Eldorado
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Fort Smith
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: McGehee
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Paragould
country: United States
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state: Arkansas
city: Pine Bluff
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Covina
country: United States
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state: California
city: Escondido
country: United States
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state: California
city: Glendale
country: United States
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state: California
city: La Mesa
country: United States
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state: California
city: Lakewood
country: United States
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state: California
city: Long Beach
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state: California
city: Los Alamitos
country: United States
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state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
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state: California
city: Los Angeles
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state: California
city: Lynwood
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state: California
city: Merced
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state: California
city: Mission Hills
country: United States
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state: California
city: Monterey Park
country: United States
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state: California
city: Mountain View
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city: Pasadena
country: United States
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city: Porterville
country: United States
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city: Riverside
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city: Sacramento
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city: Torrance
country: United States
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city: Vacaville
country: United States
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city: Visalia
country: United States
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city: Walnut Creek
country: United States
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city: Whittier
country: United States
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city: Whittier
country: United States
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city: Yuba City
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city: Colorado Springs
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city: Denver
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city: Stamford
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state: District of Columbia
city: Atlantis
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city: Brandon
country: United States
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city: Naples
country: United States
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city: Orlando
country: United States
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city: Orlando
country: United States
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city: Panama City
country: United States
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state: Florida
city: Pembroke Pines
country: United States
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city: Tampa
country: United States
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city: Tampa
country: United States
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state: Florida
city: Weston
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state: Florida
city: Zephyrhills
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state: Florida
city: Atlanta
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state: Georgia
city: Atlanta
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state: Georgia
city: Augusta
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state: Georgia
city: Augusta
country: United States
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state: Georgia
city: Macon
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state: Georgia
city: Marietta
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city: Boise
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state: Idaho
city: Meridian
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city: Crestwood
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state: Illinois
city: Evergreen Park
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city: Gurnee
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state: Illinois
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country: United States
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country: United States
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state: Indiana
city: Indianapolis
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city: Des Moines
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city: Kansas City
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city: Topeka
country: United States
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city: Madisonville
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state: Kentucky
city: Baton Rouge
country: United States
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state: Louisiana
city: Lafayatte
country: United States
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state: Louisiana
city: New Iberia
country: United States
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state: Louisiana
city: New Orleans
country: United States
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city: New Orleans
country: United States
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city: New Orleans
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Bethesda
country: United States
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state: Maryland
city: Easton
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Hagerstown
country: United States
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state: Maryland
city: Rockville
country: United States
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state: Maryland
city: Silver Spring
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Brockton
country: United States
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state: Massachusetts
city: Springfield
country: United States
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state: Massachusetts
city: Dearborn
country: United States
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state: Michigan
city: Detroit
country: United States
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state: Michigan
city: Detroit
country: United States
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state: Michigan
city: Kalamazoo
country: United States
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state: Michigan
city: Lansing
country: United States
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state: Michigan
city: Minneapolis
country: United States
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state: Minnesota
city: Columbus
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state: Mississippi
city: Gulfport
country: United States
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state: Mississippi
city: Jackson
country: United States
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state: Mississippi
city: St. Ann
country: United States
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state: Missouri
city: St. Louis
country: United States
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state: Missouri
city: St. Louis
country: United States
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state: Missouri
city: St. Peters
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Kearney
country: United States
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state: Nebraska
city: North Platte
country: United States
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state: Nebraska
city: Eatontown
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state: New Jersey
city: Livingston
country: United States
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state: New Jersey
city: Voorhees
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Bronx
country: United States
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state: New York
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Brooklyn
country: United States
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Cooperstown
country: United States
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state: New York
city: Fresh Meadows
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Port Washington
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Rosedale
country: United States
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state: New York
city: Yonkers
country: United States
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state: New York
city: Durham
country: United States
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state: North Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Hamlet
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cleveland
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facility: Novo Nordisk Investigational Site
state: Ohio
city: Columbus
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state: Ohio
city: Dayton
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state: Ohio
city: Toledo
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state: Ohio
city: Xenia
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state: Ohio
city: Bend
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state: Oregon
city: Medford
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state: Oregon
city: Roseburg
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state: Oregon
city: Allentown
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state: Pennsylvania
city: Johnstown
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state: Pennsylvania
city: Lewistown
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state: Pennsylvania
city: Meadville
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pittsburgh
country: United States
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state: Pennsylvania
city: Pittsburg
country: United States
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state: Pennsylvania
city: Providence
country: United States
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state: Rhode Island
city: Charleston
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facility: Novo Nordisk Investigational Site
state: South Carolina
city: Columbia
country: United States
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state: South Carolina
city: North Charleston
country: United States
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state: South Carolina
city: Orangeburg
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state: South Carolina
city: Santee
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state: South Carolina
city: Sumter
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state: South Carolina
city: Sioux Falls
country: United States
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state: South Dakota
city: Clarksville
country: United States
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state: Tennessee
city: Dyersburg
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Knoxville
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Nashville
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state: Tennessee
city: Nashville
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Corpus Christi
country: United States
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state: Texas
city: Corpus Christi
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
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state: Texas
city: Houston
country: United States
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state: Texas
city: Killeen
country: United States
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state: Texas
city: Lubbock
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state: Texas
city: McAllen
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state: Texas
city: San Antonio
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state: Texas
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state: Texas
city: Tyler
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state: Texas
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city: Provo
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state: Utah
city: Burlington
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state: Vermont
city: Alexandria
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state: Virginia
city: Charlottesville
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city: Chesapeake
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city: Hampton
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state: Virginia
city: Mechanicsville
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city: Bluefield
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city: Glendale
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city: Marshfield
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state: Wisconsin
city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Capital Federal
country: Argentina
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city: Capital Federal
country: Argentina
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city: Cordoba
country: Argentina
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city: Morón
country: Argentina
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city: Pergamino
country: Argentina
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city: San Miguel de Tucuman
country: Argentina
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city: Sarandí
country: Argentina
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city: Temperley
country: Argentina
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city: Curitiba
country: Brazil
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city: Fortaleza
country: Brazil
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city: Fortaleza
country: Brazil
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city: Jaboatao de Guararapes
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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city: Edmonton
country: Canada
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state: Alberta
city: Halifax
country: Canada
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state: Nova Scotia
city: Toronto
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state: Ontario
city: Montreal
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city: Greenfield Park
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country: Canada
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country: Canada
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country: Canada
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city: Thunder Bay
country: Canada
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city: Beijing
country: China
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state: Beijing
city: Beijing
country: China
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state: Beijing
city: Nanjing
country: China
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state: Jiangsu
city: Shanghai
country: China
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state: Shanghai
city: Arhus N
country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Lyon Cedex 3
country: France
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city: Montpellier Cedex 5
country: France
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country: France
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city: Nantes Cedex 1
country: France
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city: Paris
country: France
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city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Poissy
country: France
facility: Novo Nordisk Investigational Site
city: Trappes
country: France
facility: Novo Nordisk Investigational Site
city: Vichy
country: France
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Bamberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bernkastel-Kues
country: Germany
facility: Novo Nordisk Investigational Site
city: Bottrop
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Düsseldorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Elsenfeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Fürstenzell
country: Germany
facility: Novo Nordisk Investigational Site
city: Gütersloh
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Heilbronn
country: Germany
facility: Novo Nordisk Investigational Site
city: Kiel
country: Germany
facility: Novo Nordisk Investigational Site
city: Krefeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Limburg an der Lahn
country: Germany
facility: Novo Nordisk Investigational Site
city: Lüdenscheid
country: Germany
facility: Novo Nordisk Investigational Site
city: Mettmann
country: Germany
facility: Novo Nordisk Investigational Site
city: Minden
country: Germany
facility: Novo Nordisk Investigational Site
city: Nettetal
country: Germany
facility: Novo Nordisk Investigational Site
city: Passau
country: Germany
facility: Novo Nordisk Investigational Site
city: Schweinfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Straubing
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Eger
country: Hungary
facility: Novo Nordisk Investigational Site
city: Kecskemet
country: Hungary
facility: Novo Nordisk Investigational Site
city: Sopron
country: Hungary
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
city: Pune
country: India
facility: Novo Nordisk Investigational Site
city: Ashkelon
country: Israel
facility: Novo Nordisk Investigational Site
city: Hadera
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Rechovot
country: Israel
facility: Novo Nordisk Investigational Site
city: Tzriffin
country: Israel
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Brescia
country: Italy
facility: Novo Nordisk Investigational Site
city: Genova
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Modena
country: Italy
facility: Novo Nordisk Investigational Site
city: Pavia
country: Italy
facility: Novo Nordisk Investigational Site
city: Kraków
country: Poland
facility: Novo Nordisk Investigational Site
city: Krasnik
country: Poland
facility: Novo Nordisk Investigational Site
city: Kwidzyn
country: Poland
facility: Novo Nordisk Investigational Site
city: Myslenice
country: Poland
facility: Novo Nordisk Investigational Site
city: Ostrów Mazowiecka
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznann
country: Poland
facility: Novo Nordisk Investigational Site
city: Pulawy
country: Poland
facility: Novo Nordisk Investigational Site
city: Radom
country: Poland
facility: Novo Nordisk Investigational Site
city: Sieradz
country: Poland
facility: Novo Nordisk Investigational Site
city: Slupca
country: Poland
facility: Novo Nordisk Investigational Site
city: Sochaczew
country: Poland
facility: Novo Nordisk Investigational Site
city: ul Mlynska 5
country: Poland
facility: Novo Nordisk Investigational Site
city: Wejherowo
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Abrantes
country: Portugal
facility: Novo Nordisk Investigational Site
city: Amadora
country: Portugal
facility: Novo Nordisk Investigational Site
city: Braga
country: Portugal
facility: Novo Nordisk Investigational Site
city: Corroios
country: Portugal
facility: Novo Nordisk Investigational Site
city: Entroncamento
country: Portugal
facility: Novo Nordisk Investigational Site
city: Setubal
country: Portugal
facility: Novo Nordisk Investigational Site
city: Torres Vedras
country: Portugal
facility: Novo Nordisk Investigational Site
city: Villa Franca de Xira
country: Portugal
facility: Novo Nordisk Investigational Site
city: Villa Nova de Gaia
country: Portugal
facility: Novo Nordisk Investigational Site
city: Évora
country: Portugal
facility: Novo Nordisk Investigational Site
city: Ponce
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Obervatory
country: South Africa
facility: Novo Nordisk Investigational Site
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Burgos
country: Spain
facility: Novo Nordisk Investigational Site
city: Cordoba
country: Spain
facility: Novo Nordisk Investigational Site
city: Granollers
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Värnamo
country: Sweden
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Londonderry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rhyl
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kopple JD, Cheung AK, Christiansen JS, Djurhuus CB, El Nahas M, Feldt-Rasmussen B, Lange M, Mitch WE, Wanner C, Wiedemann J, Ikizler TA. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Nov;3(6):1741-51. doi: 10.2215/CJN.02760608.
citation: Raff AC, Meyer TW, Hostetter TH. New insights into uremic toxicity. Curr Opin Nephrol Hypertens. 2008 Nov;17(6):560-5. doi: 10.1097/MNH.0b013e32830f45b6.