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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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576602
First received: December 18, 2007
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • SF36 [ Time Frame: Weeks 16 and 48 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 318
Estimated Study Completion Date: February 2010
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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00576602     History of Changes
Other Study ID Numbers: MH21299
Study First Received: December 18, 2007
Last Updated: September 22, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
 Renal Insufficiency
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013