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

Kidney Disease, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194154
• Other study ID #: ML22916
• Secondary ID: 2009-015114-22
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2010
• Last updated: December 21, 2015
• Start date: September 2010
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
• Placebo
Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)		24 months	No
Secondary	Change From Baseline in Urinary Albumin Creatinine Ratio (UACR)		Baseline, 24 months	No
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		24 months	No
Secondary	Change From Baseline in Serum Creatinine Concentration		Baseline, 24 months	No
Secondary	Change From Baseline in Serum Cystatin C Concentration		Baseline, 24 months	No