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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00605345
First received: January 18, 2008
Last updated: August 17, 2016
Last verified: April 2016
  Purpose
This two 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 subcutaneously) 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: Darbepoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range [ Time Frame: Weeks 16-28 ] [ Designated as safety issue: No ]
    Key outcomes will be assessed during the first 12 weeks following the 16 weeks dose titration period, i.e. during the Efficacy Evaluation Period (EEP). Assessments performed every four weeks, beginning at week 16 up to week 28. The reference haemoglobin is defined as the mean of the two assessments recorded during the SVP (weeks -4 and -2). For the purposes of efficacy assessment the target haemoglobin concentration range will be defined as ± 1 g/dL of the reference haemoglobin concentration AND within the range 10 - 12 g/dL.


Secondary Outcome Measures:
  • Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP) [ Time Frame: Baseline to 28 weeks ] [ Designated as safety issue: No ]
    Reference haemoglobin at baseline is defined as the mean of the two assessments recorded at weeks -4 and -2. Additional assessments were then performed every 4 weeks at week 0 through week 28. Mean change was calculated as value at 28 weeks minus baseline.

  • Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-28 ] [ Designated as safety issue: No ]
  • Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-28 ] [ Designated as safety issue: No ]
    Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.

  • Percentage of Participants Needing Dose Adjustments [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
    Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

  • Incidence of RBC Transfusions [ Time Frame: Up to 28 weeks ] [ Designated as safety issue: No ]
    Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).


Enrollment: 71
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CERA Treatment Once Monthly Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc 4-weekly (starting dose)
Active Comparator: Darbepoetin Alfa Once Biweekly Drug: Darbepoetin alfa
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, > or = 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
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: NCT00605345

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00605345     History of Changes
Other Study ID Numbers: ML21058 
Study First Received: January 18, 2008
Results First Received: April 19, 2016
Last Updated: August 17, 2016
Health Authority: Spain: AEMPS

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on September 23, 2016