A Study of Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in Participants With Chronic Kidney Disease (PRIMAVERA)

Roche

Status and phase

Completed

Phase 2

Conditions

Kidney Disease, Chronic

Treatments

Drug: Methoxy polyethylene glycol-epoetin beta

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01194154

2009-015114-22

ML22916

Details and patient eligibility

About

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.

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 (<) 3000 milligram (mg)/gram (g) or total protein <3000 mg/ 24 hour urine sample where applicable

Exclusion criteria

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%