A Study of Subcutaneous Mircera, Versus no Erythropoiesis-Stimulating Agent (ESA) Therapy, in the Treatment of Anemia in Patients With Chronic Kidney Disease After Kidney Transplant

Study Overview
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Brief Summary
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This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. 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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A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

Conditions
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Anemia

Intervention / Treatment
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* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
* Drug: Supportive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; kidney transplant >=6 months and <5 years prior to randomization; anemia; no ESA therapy during 3 months prior to randomization. Exclusion Criteria: requirement for hemodialysis or peritoneal dialysis within 3 months prior to randomization; change in Hb concentration >=1.5g/dL during screening period; transfusion of red blood cells during 3 months prior to randomization; poorly controlled hypertension; significant acute or chronic bleeding within 3 months prior to randomization.

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: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: Supportive treatment<br>* As prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb concentration between baseline and efficacy evaluation period (EEP). |  | Weeks 13-16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions. |  | Throughout study | 
| SF36 |  | Weeks 16 and 48 | 
| AEs, laboratory parameters. |  | Throughout study |