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

Phase 4

Terminated

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

• Registration Number: NCT00576602
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-epoetin beta [Mircera]	-
2	Supportive treatment	-

Primary Outcome Measures

Name	Time	Method
Change in Hb concentration between baseline and efficacy evaluation period (EEP).	Weeks 13-16

Secondary Outcome Measures

Name	Time	Method
SF36	Weeks 16 and 48
AEs, laboratory parameters.	Throughout study
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