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Completed

NCT Number: NCT00605345

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alicante, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

darbepoetin alfa

Drug

As prescribed

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

120, 200 or 360 micrograms sc 4-weekly (starting dose)

Primary outcomes

  1. The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range

    Time frame: Weeks 16-28

    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 outcomes

  1. Mean Change in Hb Concentration From Baseline to Efficacy Evaluation Period (EEP)

    Time frame: Baseline to 28 weeks

    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.

  2. Percentage of Participants Maintaining Hb Concentration in 10-12 g/dL Range Throughout the Efficacy Evaluation Period (EEP)

    Time frame: Weeks 16-28

  3. Mean Time Spent in 10-12g/dL Range During the Efficacy Evaluation Period (EEP)

    Time frame: Weeks 16-28

    Efficacy Evaluation Period was the 12 weeks following 16 weeks of treatment in the Dose Titration Period.

  4. Percentage of Participants Needing Dose Adjustments

    Time frame: Up to 28 weeks

    Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

  5. Incidence of RBC Transfusions

    Time frame: Up to 28 weeks

    Assessment of the Dose Titration Period of 16 weeks of treatment and following 12 weeks, known as the Efficacy Evaluation Period (EEP).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2008
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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