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Completed

NCT Number: NCT00442702

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. 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

Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, >=18 years of age;
  • chronic kidney disease, not requiring dialysis;
  • receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion criteria

  • overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
  • transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
  • active malignant disease;
  • previous treatment with Mircera.

Treatment and study plan

Mircera

Drug

Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month.

Other names: RO0503821, Methoxy polyethylene glycol-epoetin beta

darbepoetin alfa

Drug

As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.

Other names: Aranesp®

Primary outcomes

  1. Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period

    Time frame: Baseline (measurements at Week -4, Week -2 and Day 1) and Evaluation Period (Months 8 and 9; measurements twice a month and at the final visit).

    A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.

Secondary outcomes

  1. Change in Hemoglobin Concentration From Baseline Over Time

    Time frame: From Baseline to 9 months; blood samples for hemoglobin measurements were taken twice a month, at each study visit.

  2. Number of Participants With Red Blood Cell (RBC) Transfusions

    Time frame: From randomization to Month 9

    Red blood cell (RBC) transfusions could be given during the treatment period in case of medical need, i.e., in severely anemic patients with recognized symptoms or signs of anemia (e.g., in patients with acute blood loss, with severe angina, or whose Hemoglobin decreased to critical levels). The number of participants who had at least one red blood cell transfusion during the entire study, during the Titration Period and during the Evaluation Period is presented. Participants who received more than one transfusion within a defined period are only counted once.

  3. Participants With Adverse Events

    Time frame: Randomization to Month 10 (final visit)

    Adverse events were collected during the treatment period (from the first treatment dose) up to 30 days after last dose or at least until the date of last contact if the date of last contact occurred after the specified 30 day period.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2007
Registry last updated
Dec 19, 2011

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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