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 4TerminatedNCT00576602

Hoffmann-La Roche1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

Unnamed facility

Edegem, Belgium

Unnamed facility

Ghent, Belgium

Unnamed facility

Leuven, Belgium

Unnamed facility

Amiens, France

Unnamed facility

Caen, France

Unnamed facility

Le Kremlin-Bicêtre, France

Unnamed facility

Nice, France

Unnamed facility

Paris, France

Unnamed facility

Toulouse, France

Unnamed facility

Tours, France

...and 10 more locations

Outcomes

Primary Outcomes

Change in Hb concentration between baseline and efficacy evaluation period (EEP).

Time frame: Weeks 13-16

Secondary Outcomes

Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.

Time frame: Throughout study

SF36

Time frame: Weeks 16 and 48

AEs, laboratory parameters.

Time frame: Throughout study