Clinical trial NCT00090753: A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Official title: An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-09-06
Enrollment: 1228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Adult patients (≥ 18 years old) with chronic renal anemia
* Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
* Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
* Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%

Exclusion Criteria:

* Poorly controlled hypertension
* History of epileptic seizure
* Pure red cell aplasia
* Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
* High likelihood of early withdrawal or interruption of the study
* Active malignant disease (except non-melanoma skin cancer)
* Life expectancy less than 12 months
* Pregnancy or breast-feeding

Primary outcomes:
measure: Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
timeFrame: Baseline to the end of the study (Up to 49 Months)
Secondary outcomes:
measure: Percentage of Patients Who Had at Least 1 Adverse Event
timeFrame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Covina
country: United States
state: California
city: Encino
country: United States
state: California
city: Irvine
country: United States
state: California
city: Los Alamitos
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Monterey Park
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Stanford
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Maywood
country: United States
state: Illinois
city: South Holland
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Columbus
country: United States
state: Mississippi
city: Tupelo
country: United States
state: Mississippi
city: St Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Paterson
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Mount Airy
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oregon City
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Lewistown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Clayton
country: Australia
city: Gosford
country: Australia
city: Liverpool
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
city: Graz
country: Austria
city: Aalst
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Liberec
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Aalborg
country: Denmark
city: Odense
country: Denmark
city: Roskilde
country: Denmark
city: HUS
country: Finland
city: Tampere
country: Finland
city: Bayonne
country: France
city: Bois Guillaume
country: France
city: Bordeaux
country: France
city: Boulogne
country: France
city: Cabestany
country: France
city: Caen
country: France
city: Chambery
country: France
city: Colmar
country: France
city: Hyeres
country: France
city: La Tronche
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Montpellier
country: France
city: Nantes
country: France
city: Nimes
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Poitiers
country: France
city: Saint Ouen
country: France
city: Saint-germain-en-laye
country: France
city: Salouël
country: France
city: Tarbes
country: France
city: Thionville
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Bad Hersfeld
country: Germany
city: Berlin
country: Germany
city: Dortmund
country: Germany
city: Erlangen
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Stuttgart
country: Germany
city: Villingen-schwenningen
country: Germany
city: Wiesbaden
country: Germany
city: Wiesloch
country: Germany
city: Wuppertal
country: Germany
city: Alexandroupolis
country: Greece
city: Ioannina
country: Greece
city: Larissa
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Bergamo
country: Italy
city: Cagliari
country: Italy
city: Cremona
country: Italy
city: Cuneo
country: Italy
city: Genova
country: Italy
city: Lecco
country: Italy
city: Livorno
country: Italy
city: Lodi
country: Italy
city: Messina
country: Italy
city: Mestre
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Prato
country: Italy
city: Reggio Calabria
country: Italy
city: S Fermo Della Battaglia
country: Italy
city: Venezia
country: Italy
city: Cuernavaca
country: Mexico
city: Mexico City
country: Mexico
city: Heerlen
country: Netherlands
city: Trondheim
country: Norway
city: Panama City
country: Panama
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Rzeszow
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wolomin
country: Poland
city: Wroclaw
country: Poland
city: Setubal
country: Portugal
city: Ponce
country: Puerto Rico
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Soweto
country: South Africa
city: Alcorcon
country: Spain
city: Alicante
country: Spain
city: Almería
country: Spain
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Córdoba
country: Spain
city: Hospitalet de Llobregat
country: Spain
city: La Coruna
country: Spain
city: Lerida
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Oviedo
country: Spain
city: Palma de Mallorca
country: Spain
city: Palma de Mallorca
country: Spain
city: Salamanca
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
city: Huddinge
country: Sweden
city: Karlstad
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Aarau
country: Switzerland
city: Lausanne
country: Switzerland
city: Lausanne
country: Switzerland
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Chonburi
country: Thailand
city: Phitsanulok
country: Thailand
city: Belfast
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Carshalton
country: United Kingdom
city: Dundee
country: United Kingdom
city: Exeter
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
city: Swansea
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: