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

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00576602

Enrollment

Registered

2007-12-19

Start date

2007-12-31

Completion date

2008-07-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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.

Interventions

DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]

Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks

DRUGSupportive treatment

As prescribed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Belgium, France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026