Clinical trial NCT00440466: PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Official title: A Randomized, Open-label, Multicenter Study of Epoetin Alfa Comparing Two Extended Dosing Regimens, Once-every-two-weeks and Once-every-four-weeks, With the Once-weekly Dosing Regimen for Maintenance Treatment in Anemic Subjects With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Renal Diseases
Keywords: Anemia
Reduction in the number of erythrocytes
Hemoglobin low level
Red blood cell deficiency
Procrit
Epoetin alfa
Chronic kidney disease
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 430
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: The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week

Detailed description: A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once every-2-weeks and once every-4-weeks with the once-weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 400 patients will be included. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis and who are already maintaining anemia with epoetin alfa administered once weekly. The study is 40 to 42 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: once-a-week injection (Group 1), or once every-2-weeks injection (Group 2), or once every-4-weeks injection (Group 3). The maximum volume per injection will not be more than 1 mL, therefore some patients may receive more than one injection per dose. The study treatment includes a period to convert to the new dosing regimen, and a subsequent stable maintenance treatment period. After the initial dose, hemoglobin will be measured on a weekly basis and used to determine adjustments in dose for each patient. The primary hypothesis is that the average change in hemoglobin level in the groups that received epoetin alfa once every 2 weeks or once every 4 weeks is not lower than the change in hemoglobin level in the group that received epoetin alfa only once a week. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety. Approximately 1 mL of epoetin alfa will be injected under the skin either once a week, once every 2 weeks, or once every 4 weeks (maximum doses of 20,000 IU once a week, 40, 000 IU every 2 weeks, or 80,000 IU every 4 weeks, respectively) for up to 36 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Meet the diagnostic criteria for chronic kidney disease, defined as a glomerular filtration rate (GFR) \>=15 mL/min per 1.73 m2 and \<60 mL/min per 1.73 m2 (Stages 3 and 4) as calculated by the central laboratory
* Hemoglobin level between 10.0 and 11.9 g/dL during the 4 weeks before randomization
* History of increase in hemoglobin after the initial dose
* Stable dose of epoetin alfa given once-weekly before randomization.

Exclusion Criteria:

* Uncontrolled hypertension
* Iron deficiency
* iron overload
* severe congestive heart failure
* Active infection
* Recent heart attack, Stroke or blood clot.

Primary outcomes:
measure: Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment
timeFrame: from baseline (Week 1) to the last 12 weeks of treatment
Secondary outcomes:
measure: Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
timeFrame: Weeks 13-37
Other outcomes:
measure: Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
timeFrame: 36 weeks of treatment
measure: Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
timeFrame: 36 weeks of treatment
measure: Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
timeFrame: 36 weeks of treatment
measure: Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
timeFrame: 36 weeks of treatment
measure: Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
timeFrame: 36 weeks of treatment
measure: Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
timeFrame: 36 weeks of treatment
measure: Number of Participants Who Died
timeFrame: 36 weeks of treatment
Locations:
city: Chula Vista
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Lynwood
country: United States
state: California
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Dimas
country: United States
state: California
city: West Hills
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Springhill
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Evergreen Park
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Methuen
country: United States
state: Massachusetts
city: Plymouth
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Picayune
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Great Neck
country: United States
state: New York
city: New York
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Monroe
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Maumee
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Bamberg
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Rock Hill
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Fountain Valley
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Petersburg
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: