A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for Maintenance Treatment of Anemia in Kidney Transplant Recipients.

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Darbepoetin alfa

• Registration Number: NCT00605345
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-18
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-31
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2016-04
• Results First Submitted: 2016-04-19
• Results First Submitted QC: 2016-06-24
• Results First Posted: 2016-08-05
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• adult patients, > or = 18 years of age;
• kidney transplant recipients with stage 3 or stage 4 chronic kidney disease;
• functioning graft of > 6 months and < 10 years after kidney transplantation, with no signs of acute rejection;
• stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension;
• significant acute or chronic bleeding;
• need for dialysis therapy expected in next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CERA Treatment Once Monthly	methoxy polyethylene glycol-epoetin beta [Mircera]	-
Darbepoetin Alfa Once Biweekly	Darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range	Weeks 16-28	Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.

Secondary Outcome Measures

Name	Time	Method
Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)	Weeks 16-28	Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.
Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)	Baseline to 28 weeks	Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.
Percentage of Participants Needing Dose Adjustments	Up to 28 weeks	Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).
Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)	Weeks 16-28
Incidence of RBC Transfusions	Up to 28 weeks	Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).