A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

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

Sponsors

Lead Sponsor: Hoffmann-La Roche

Source Hoffmann-La Roche
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.

Overall Status Completed
Start Date December 2007
Completion Date October 2009
Primary Completion Date October 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Hemoglobin (Hb) Response Baseline up to Week 28
Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period Baseline (measurements at Week -2, Week -1 and Day 1) and Evaluation Period (Week 22, Week 24, Week 26, Week 28)
Secondary Outcome
Measure Time Frame
Hemoglobin (Hb) Concentration Over the Time Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and final visit (Week 29)
Time to Hemoglobin Response Baseline up to Week 28
Percentage of Participants With Red Blood Cell (RBC) Transfusions Baseline up to Week 28
Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL Baseline to Week 8
Percentage of Participants With Stable Hemoglobin Response Baseline to Week 28
Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response Baseline to Week 28
Enrollment 307
Condition
Intervention

Intervention Type: Drug

Intervention Name: Methoxy polyethylene glycol-epoetin beta

Description: 1.2 mcg/kg SC monthly, starting dose

Arm Group Label: Mircera

Intervention Type: Drug

Intervention Name: Darbepoetin alfa

Description: 0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose

Arm Group Label: Darbepoetin Alfa

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Location
Facility:
| Adelaide, 5011, Australia
| Clayton, 3186, Australia
| Gosford, 2250, Australia
| Parkville, 3052, Australia
| Reservoir, 3073, Australia
| Aalst, 9300, Belgium
| Roeselare, 8800, Belgium
| Edmonton, Alberta, T6G 2B7, Canada
| London, Ontario, N6A 5A5, Canada
| Toronto, Ontario, M4N 3M5, Canada
| Montreal, Quebec, H1T 2M4, Canada
| Cahors, 46005, France
| Clermont-ferrand, 63000, France
| Limoges, 87042, France
| Lyon, 69437, France
| Nice, 06002, France
| Paris, 75651, France
| Berlin, 13353, Germany
| Bonn, 53127, Germany
| Heilbronn, 74076, Germany
| Homburg/saar, 66424, Germany
| Alexandroupolis, 68100, Greece
| Larissa, 41 110, Greece
| Thessaloniki, 54636, Greece
| Volos, 38222, Greece
| Hong Kong, Hong Kong
| Baja, 6500, Hungary
| Budapest, 1071, Hungary
| Esztergom, 2500, Hungary
| Hatvan, 3000, Hungary
| Szigetvar, 7390, Hungary
| Haifa, 34362, Israel
| Kfar Saba, 44281, Israel
| Petach Tikva, 49100, Israel
| Como, 22100, Italy
| Lecco, 23900, Italy
| Lodi, 26900, Italy
| Mestre, 30174, Italy
| Modena, 41100, Italy
| Pavia, 27100, Italy
| Seoul, 120-752, Korea, Republic of
| Seoul, 133-792, Korea, Republic of
| Seoul, Korea, Republic of
| Gdansk, 80-211, Poland
| Katowice, 40-027, Poland
| Krakow, 31-501, Poland
| Lodz, 90-153, Poland
| Radom, 26-610, Poland
| Rzeszow, 35-055, Poland
| Sieradz, 98-200, Poland
| Szczecin, 70-111, Poland
| Warszawa, 02-006, Poland
| Wroclaw, 50-417, Poland
| Moscow, 117036, Russian Federation
| Moscow, 125101, Russian Federation
| Moscow, 129110, Russian Federation
| Saratov, 410053, Russian Federation
| St Petersburg, 191015, Russian Federation
| St Petersburg, 195067, Russian Federation
| St Petersburg, 197089, Russian Federation
| St Petersburg, 197110, Russian Federation
| Barcelona, 08025, Spain
| Barcelona, 08907, Spain
| Madrid, 28046, Spain
| Madrid, 28922, Spain
| Palma de Mallorca, 07014, Spain
| Sevilla, 41009, Spain
| Sevilla, 41013, Spain
| Valencia, 46017, Spain
| Taichung, 407, Taiwan
| Taipei, 100, Taiwan
| Bangkok, 10400, Thailand
| Bangkok, 10700, Thailand
| Bangkok, Thailand
| Nakhon Ratchasima, 30000, Thailand
| Pathumthani, 12120, Thailand
Location Countries

Australia

Belgium

Canada

France

Germany

Greece

Hong Kong

Hungary

Israel

Italy

Korea, Republic of

Poland

Russian Federation

Spain

Taiwan

Thailand

Verification Date

September 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mircera

Type: Experimental

Description: Participants will receive Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.

Label: Darbepoetin Alfa

Type: Active Comparator

Description: Participants will receive darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov