A Study of Mircera in Patients With Chronic Kidney Disease (PRIMAVERA)
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194154
First received: August 25, 2010
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
This randomized, single-blind, proof-of-concept study will investigate the protective effects of early treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on renal disease progression. Patients will be randomized to receive 30 µg Mircera as subcutaneous injection once monthly or matching placebo. Depending on change of hemoglobin values, the dose of Mircera can be adjusted to 50 µg or 75 µg once monthly. The anticipated time on study treatment is 24 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Disease, Chronic |
Drug: Mircera Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled, Single-blind, Proof-of-concept-study to Investigate the Protective Effects of Early Treatment With C.E.R.A. in Patients With Chronic Kidney Disease on Renal Disease Progression (PRIMAVERA-Study) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- To investigate the protective effects of early treatment with Mircera on the decline of renal function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary protein creatinine ratio [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 241 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Mircera
30 mcg subcutaneous injection once monthly with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL
|
| Placebo Comparator: 2 |
Drug: Placebo
subcutaneous injection once monthly
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, 18 years of age
- For diabetic patients: Type 2 diabetes mellitus with HbA1c >7% or anti-diabetic treatment
- For renal allograft recipients: Status between 6 months and 10 years post transplantation
- Chronic kidney disease stage III
- Urinary albumine-to-creatinine ratio between >100 and <1000 mg/g creatinine
Exclusion Criteria:
- Hb-level <1 or 14 g/dL
- Initiation of angiotensin converting enzyme inhibitor, angiotensin 2 receptor blocker or aliskiren treatment less than 3 months before enrolment
- Iron deficiency
- HbA1c >9%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194154
Locations
| Germany | |
| Aachen, Germany, 52057 | |
| Augsburg, Germany, 86157 | |
| Bad König, Germany, 64732 | |
| Berlin, Germany, 12203 | |
| Berlin, Germany, 12435 | |
| Berlin, Germany, 10117 | |
| Bovenden, Germany, 37120 | |
| Dresden, Germany, 01307 | |
| Düsseldorf, Germany, 40210 | |
| Essen, Germany, 45147 | |
| Frankfurt, Germany, 60596 | |
| Heidelberg, Germany, 69120 | |
| Heilbronn, Germany, 74076 | |
| Hilden, Germany, 40724 | |
| Homburg/Saar, Germany, 66424 | |
| Hoyerswerda, Germany, 02977 | |
| Kaiserslautern, Germany, 67655 | |
| Kiel, Germany, 24106 | |
| Köln, Germany, 51109 | |
| Lübeck, Germany, 23562 | |
| Mannheim, Germany, 68309 | |
| Mettmann, Germany, 40822 | |
| Muenchen, Germany, 80336 | |
| München, Germany, 81377 | |
| München-Bogenhausen, Germany, 81925 | |
| Münster, Germany, 48149 | |
| Neckarsulm, Germany, 74172 | |
| Neunkirchen/Saar, Germany, 66538 | |
| Saarlouis, Germany, 66740 | |
| Ulm, Germany, 89077 | |
| Velbert, Germany, 42549 | |
| Villingen-Schwenningen, Germany, 78054 | |
| Wiesbaden, Germany, 65191 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01194154 History of Changes |
| Other Study ID Numbers: | ML22916, 2009-015114-22 |
| Study First Received: | August 25, 2010 |
| Last Updated: | May 23, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Chronic Disease Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Disease Attributes Pathologic Processes Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013