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

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Roche

Status and phase

Completed
Phase 3

Conditions

Anemia

Treatments

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: Darbepoetin alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605345
ML21058

Details and patient eligibility

About

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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

71 participants in 2 patient groups

CERA Treatment Once Monthly
Experimental group
Treatment:
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Darbepoetin Alfa Once Biweekly
Active Comparator group
Treatment:
Drug: Darbepoetin alfa

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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