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

This study has been terminated.
(poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576602
First received: December 18, 2007
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: Supportive treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Hb concentration between baseline and efficacy evaluation period (EEP). [ Time Frame: Weeks 13-16 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576602

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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576602     History of Changes
Other Study ID Numbers: MH21299 
Study First Received: December 18, 2007
Last Updated: November 3, 2016

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Hematinics

ClinicalTrials.gov processed this record on January 19, 2017