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

November 3, 2016 updated by: Hoffmann-La Roche

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.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • France
      • Amiens, France
      • Caen, France
      • Le Kremlin-Bicetre, France
      • Nice, France
      • Paris, France
      • Toulouse, France
      • Tours, France
  • Germany
      • Berlin, Germany
      • Frankfurt AM Main, Germany
      • Kaiserslautern, Germany
      • Kiel, Germany
      • Munchen, Germany
  • Italy
      • Bari, Italy
  • Spain
      • Barcelona, Spain
      • Santander, Spain
      • Sevilla, Spain
  • United Kingdom
      • London, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose of 0.6 micrograms/kg sc every 2 weeks
Active Comparator: 2
Drug: Supportive treatment
As prescribed

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs, laboratory parameters.
Time Frame: Throughout study
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.
Time Frame: Throughout study
Throughout study
SF36
Time Frame: Weeks 16 and 48
Weeks 16 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH21299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on methoxy polyethylene glycol-epoetin beta [Mircera]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe