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Completed

NCT Number: NCT00605293

A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

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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

Badajoz, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic renal anemia;
  • continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
  • regular hemodialysis for greater than or equal to (>=) 3 months

Exclusion criteria

  • transfusion of red blood cells during previous 2 months
  • poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

120, 200 or 360 micrograms iv/month (starting dose)

Other names: Mircera; C.E.R.A

Epoetin alfa

Drug

As prescribed

Primary outcomes

  1. Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP

    Time frame: EEP (Week 16 to 23)

    Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.

Secondary outcomes

  1. Change in Hb Concentrations Between Baseline SVP and the EEP

    Time frame: SVP (Week -4 to -1), EEP (Week 16 to 23)

    Change in Hb concentration between baseline SVP and the EEP was evaluated by subtracting the mean of Hb concentration during the SVP (Weeks -4 to -1) with the mean of Hb concentration during the EEP (Weeks 16 to 23).

  2. Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP

    Time frame: EEP (Week 16 to 23)

    Participants who maintained Hb concentration between 10 to 12 g/dL throughout the EEP are reported.

  3. Mean Time Spent in Hb Range 10-12 g/dL

    Time frame: SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23)

  4. Percentage of Participants Who Required Dose Adjustments During the DTP and EEP

    Time frame: DTP (Week 0 to 15) and EEP (Week 16 to 23)

  5. Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP

    Time frame: DTP (Week 0 to 15) up to EEP (Week 16 to 23)

    RBC transfusions could be given during the study in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose hemoglobin decreased to critical levels).

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 Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 31, 2008
Registry last updated
May 13, 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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