Phase 3
Completed N=307
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Renal Anemia, Chronic
Source: ClinicalTrials.gov NCT00559273 ↗
Enrolled (actual)
307
Serious AEs
22.0%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Hemoglobin (Hb) Response — 94.12; 93.51 percentage of participants — p=<0.0001
◆ Published Evidence
Established
47citations · ~16 / year
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
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.
Linked Publications
-
Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hemoglobin (Hb) Response |
94.12; 93.51 | <0.0001 sig |
| PRIMARY Change in Hemoglobin (Hb) Concentration Between Baseline and Evaluation Period |
1.66; 1.69 | <0.0001 sig |
| SECONDARY Hemoglobin (Hb) Concentration Over the Time |
9.53; 9.53; 10.22; 10.14; 10.37; 10.74 | — |
| SECONDARY Time to Hemoglobin Response |
43; 29 | — |
| SECONDARY Percentage of Participants With Red Blood Cell (RBC) Transfusions |
3.3; 6.5 | — |
| SECONDARY Percentage of Participants Who Had at Least 1 Hemoglobin Value Exceeding 12.0 g/dL |
25.8; 47.7 | — |
| SECONDARY Percentage of Participants With Stable Hemoglobin Response |
68.63; 72.73 | — |
| SECONDARY Percentage of Participants Who Required Dose Adjustments to Achieve a Stabilized Response |
41.9; 18.8; 8.6; 19.6; 11.4; 18.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT00559273) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.