Clinical trial NCT00559273: A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Official title: An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Anemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 307
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 study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance \[CrCl\]/ glomerular filtration rate \[GFR\] 30 to 59 milliliter per minutes per 1.73 meter square \[mL/min/1.73m\^2\]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m\^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation
* Anemia defined as baseline Hb concentration less than (\<) 10.5 gram per deciliter (g/dL)

Exclusion Criteria:

* Previous therapy with any ESA within 12 weeks prior to screening
* Renal allograft in place
* Immunosuppressive therapy in the 12 weeks prior to screening
* Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening

Primary outcomes:
measure: Percentage of Participants With Hemoglobin (Hb) Response
timeFrame: Baseline up to Week 28
measure: Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period
timeFrame: Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
Secondary outcomes:
measure: Hemoglobin (Hb) Concentration Over the Time
timeFrame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
measure: Time to Hemoglobin Response
timeFrame: Baseline up to Week 28
measure: Percentage of Participants With Red Blood Cell (RBC) Transfusions
timeFrame: Baseline up to Week 28
measure: Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL
timeFrame: Baseline to Week 8
measure: Percentage of Participants With Stable Hemoglobin Response
timeFrame: Baseline to Week 28
measure: Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response
timeFrame: Baseline to Week 28
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Clayton
country: Australia
city: Gosford
country: Australia
city: Parkville
country: Australia
city: Reservoir
country: Australia
city: Aalst
country: Belgium
city: Roeselare
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Cahors
country: France
city: Clermont-ferrand
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Heilbronn
country: Germany
city: Homburg/saar
country: Germany
city: Alexandroupolis
country: Greece
city: Larissa
country: Greece
city: Thessaloniki
country: Greece
city: Volos
country: Greece
city: Hong Kong
country: Hong Kong
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Esztergom
country: Hungary
city: Hatvan
country: Hungary
city: Szigetvar
country: Hungary
city: Haifa
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Como
country: Italy
city: Lecco
country: Italy
city: Lodi
country: Italy
city: Mestre
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
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: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Nakhon Ratchasima
country: Thailand
city: Pathumthani
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: