Status:
COMPLETED
A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Kidney Disease, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. ...
Eligibility Criteria
Inclusion
- 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 (\<) 3000 milligram (mg)/gram (g) or total protein \<3000 mg/ 24 hour urine sample where applicable
Exclusion
- Hemoglobin-level \< 11 or \> 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%
Key Trial Info
Start Date :
September 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2015
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01194154
Start Date
September 30 2010
End Date
March 31 2015
Last Update
May 10 2017
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Uniklinik RWTH Aachen; Med. Klinik II; Klinik für Nephrologie und klinische Immunologie
Aachen, Germany, 52057
2
Dialysepraxis Dr. Stallforth, Dr. Kirschner, Dr. Al-Sarraf und Dr. Pawlik
Augsburg, Germany, 86157
3
KfH Kuratorium für Dialyse und Nierentransplantation e.V. im Kurhaus
Bad König, Germany, 64732
4
Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie
Berlin, Germany, 10117