Clinical trial NCT00442702: A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Official title: An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 228
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 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease, not requiring dialysis;
* receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.

Exclusion Criteria:

* overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
* transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
* active malignant disease;
* previous treatment with Mircera.

Primary outcomes:
measure: Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period
timeFrame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).
Secondary outcomes:
measure: Change in Hemoglobin Concentration From Baseline Over Time
timeFrame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.
measure: Number of Participants With Red Blood Cell (RBC) Transfusions
timeFrame: From randomization to Month 9
measure: Participants With Adverse Events
timeFrame: Randomization to Month 10 (final visit)
Other outcomes:
Locations:
city: Granada Hills
country: United States
state: California
city: Lauderdale Lakes
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Mineola
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Oregon City
country: United States
state: Oregon
city: Providence
country: United States
state: Rhode Island
city: Chattanooga
country: United States
state: Tennessee
city: Salem
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Adelaide
country: Australia
city: Gosford
country: Australia
city: Lismore
country: Australia
city: Reservoir
country: Australia
city: Richmond
country: Australia
city: Aalst
country: Belgium
city: Roeselare
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: St John's
country: Canada
state: Newfoundland and Labrador
city: Kingston
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Marianske Lazne
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 4
country: Czech Republic
city: Praha
country: Czech Republic
city: La Tronche
country: France
city: Nantes
country: France
city: Orleans
country: France
city: Paris
country: France
city: Rennes
country: France
city: St Priest En Jarez
country: France
city: Strasbourg
country: France
city: Bad Hersfeld
country: Germany
city: Bad König
country: Germany
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Coburg
country: Germany
city: Demmin
country: Germany
city: Dortmund
country: Germany
city: München
country: Germany
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Esztergom
country: Hungary
city: Hodmezovasarhely
country: Hungary
city: Kalocsa
country: Hungary
city: Kecskemet
country: Hungary
city: Szigetvar
country: Hungary
city: VAC
country: Hungary
city: Hadera
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Nahariya
country: Israel
city: Rehovot
country: Israel
city: Brescia
country: Italy
city: Chieti
country: Italy
city: Ferrara
country: Italy
city: Genova
country: Italy
city: La Spezia
country: Italy
city: Lecco
country: Italy
city: Lodi
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Prato
country: Italy
city: Roma
country: Italy
city: S Fermo Della Battaglia
country: Italy
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Radom
country: Poland
city: Rzeszow
country: Poland
city: Sieradz
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Ciudad Real
country: Spain
city: Hospitalet de Llobregat
country: Spain
city: La Coruna
country: Spain
city: Lerida
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Partida La Ceñuela. Torreviej
country: Spain
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Bradford
country: United Kingdom
city: Exeter
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: