Phase 2
Completed N=241
A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
Kidney Disease, Chronic
Source: ClinicalTrials.gov NCT01194154 ↗
Enrolled (actual)
241
Serious AEs
38.3%
Results posted
Jun 2016
Primary outcomePrimary: Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4) — 3.04; 0.82 mL/min/1.73m^2/year — p=0.657
Summary
This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera in participants with chronic kidney disease on renal disease progression. Participants will be randomly assigned to receive 30 microgram (mcg) Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin values, the dose of Mircera can be adjusted to 50 mcg or 75 mcg once monthly. The anticipated time on study treatment is 24 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Modification of Diet in Renal Disease With 4 Variables (MDRD-4) |
3.04; 0.82 | 0.657 |
| SECONDARY Yearly Reduction Rate of Estimated Glomerular Filtration Rate (eGFR) Calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) |
3.02; 0.78 | 0.709 |
| SECONDARY Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Month 24 |
53.18; 52.48; -2.97; -2.08 | — |
| SECONDARY Change From Baseline in Serum Creatinine Concentration at Month 24 |
147.8; 149.3; 7.04; 4.04 | — |
| SECONDARY Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Month 24 |
261.1; 237.3; 173.8; 70.59 | — |
| SECONDARY Change From Baseline in Serum Cystatin C Concentration at Month 24 |
1.79; 1.76; 0.10; 0.02 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
35.6; 41.0; 84.7; 86.3 | — |
Eligibility Criteria
Inclusion Criteria
- For diabetic participants: Type 2 diabetes mellitus with glycated hemoglobin (HbA1c) greater than (>) 7% or anti-diabetic treatment
- For renal allograft recipients: Status at least 6 months post transplantation
- Chronic kidney disease stage III
- Urinary albumin-to-creatinine ratio less than ( 14 g/deciliter (dL)
- Average systolic blood pressure (SBP) > 140 millimeter of mercury (mm Hg) or average diastolic blood pressure (DBP) > 90 mm Hg
- Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
- Present and known iron deficiency
- HbA1c >9%
Data sourced from ClinicalTrials.gov (NCT01194154). 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.