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A Study Comparing Subcutaneous Mircera and Darbepoetin Alfa for the Maintenance Treatment of Anemia in Kidney Transplant Recipients.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00605345
First received: January 18, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms sc) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. 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: Darbepoetin alfa
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera Versus Darboepoetin Alfa for the Maintenance of Haemoglobin Levels in Renal Transplant Recipients With Chronic Renal Anaemia.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration within +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12 g/dL range. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 71
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc 4-weekly (starting dose)
Active Comparator: 2 Drug: Darbepoetin alfa
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 recipients with stage 3 or stage 4 chronic kidney disease;
  • functioning graft of >6 months and <10 years after kidney transplantation, with no signs of acute rejection;
  • stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • need for dialysis therapy expected in next 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605345

Locations
Spain
Alicante, Spain, 03010
Badajoz, Spain, 06080
Badalona, Spain, 08915
Barakaldo, Spain, 48903
Barcelona, Spain, 08003
Barcelona, Spain, 08025
Barcelona, Spain, 08036
Ciudad Real, Spain, 13005
Córdoba, Spain, 14004
Galdakao, Spain, 48960
Granada, Spain, 18014
Hospitalet de Llobregat, Spain, 08907
La Coruna, Spain, 15006
Madrid, Spain, 28007
Madrid, Spain, 28040
Madrid, Spain, 28222
Madrid, Spain, 28041
Santander, Spain, 39008
Santiago de Compostela, Spain, 15706
Valencia, Spain, 46017
Valladolid, Spain, 47005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00605345     History of Changes
Other Study ID Numbers: ML21058
Study First Received: January 18, 2008
Last Updated: March 15, 2011
Health Authority: Spain: AEMPS

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013