Clinical trial NCT00576602: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hb concentration between baseline and efficacy evaluation period (EEP).
timeFrame: Weeks 13-16
Secondary outcomes:
measure: Change in Hb concentration, percentage of patients maintaining average Hb concentration within target range, percentage of patients requiring dose adjustments, incidence of RBC transfusions.
timeFrame: Throughout study
measure: SF36
timeFrame: Weeks 16 and 48
measure: AEs, laboratory parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Amiens
country: France
city: Caen
country: France
city: Le Kremlin-Bicetre
country: France
city: Nice
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Berlin
country: Germany
city: Frankfurt AM Main
country: Germany
city: Kaiserslautern
country: Germany
city: Kiel
country: Germany
city: Munchen
country: Germany
city: Bari
country: Italy
city: Barcelona
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: