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

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.

Conditions
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Anemia

Intervention / Treatment
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* Drug: Darbepoetin alfa
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CERA Treatment Once Monthly<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 120, 200 or 360 micrograms sc 4-weekly (starting dose)<br>|
| Active Comparator: Darbepoetin Alfa Once Biweekly<br> | Drug: Darbepoetin alfa<br>* As prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range | 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. | Weeks 16-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) | 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. | Baseline to 28 weeks | 
| Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) |  | Weeks 16-28 | 
| Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) | Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period. | Weeks 16-28 | 
| Percentage of Participants Needing Dose Adjustments | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Up to 28 weeks | 
| Incidence of RBC Transfusions | Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP). | Up to 28 weeks |