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NCT Number: NCT00442793

A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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

Beijing, China

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, >=18 years of age;
  • chronic renal anemia requiring dialysis;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
  • adequate iron status.

Exclusion criteria

  • previous epoetin treatment within 8 weeks prior to screening;
  • failing renal graft in place;
  • bleeding episode necessitating transfusion within 8 weeks prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.

Treatment and study plan

Epoetin beta

Drug

As prescribed, 3 times weekly

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

0.4 micrograms/kg iv every 2 weeks

Primary outcomes

  1. Hb response rate

    Time frame: Weeks 0-24

  2. Change in Hb concentration between baseline and evaluation period

    Time frame: Months 4-6

Secondary outcomes

  1. Hb over time

    Time frame: Throughout study

  2. Time to Hb response

    Time frame: Throughout study

  3. RBC transfusions

    Time frame: Weeks 0-24

  4. AEs, laboratory parameters, vital signs

    Time frame: Throughout study

  5. Serum concentration of Mircera

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2007
Registry last updated
Nov 2, 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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