A Study of Mircera in Patients With Chronic Kidney Disease (PRIMAVERA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01194154
First received: August 25, 2010
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

This randomized, single-blind, proof-of-concept study will investigate the prote ctive effects of early treatment with Mircera (methoxy polyethylene glycol-epoet in beta) in patients with chronic kidney disease on renal disease progression. P atients will be randomized to receive 30 µg Mircera as subcutaneous injection on ce monthly or matching placebo. Depending on change of hemoglobin values, the do se of Mircera can be adjusted to 50 µg or 75 µg once monthly. The anticipated ti me 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 (Subject)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 12435
Berlin, Germany, 12203
Berlin, Germany, 10117
Bovenden, Germany, 37120
Dresden, Germany, 01307
Düsseldorf, Germany, 40210
Essen, Germany, 45122
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: October 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Chronic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Disease Attributes
Pathologic Processes
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 29, 2014