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Completed

NCT Number: NCT00699348

A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, 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

Acireale, Italy

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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 intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
  • Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

Exclusion criteria

  • Transfusion of red blood cells during previous 2 months;
  • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
  • Active malignant disease (except non-melanoma skin cancer).

Treatment and study plan

Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

Drug

Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.

Other names: Mircera

Primary outcomes

  1. Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range

    Time frame: Week 17 up to Week 24

    Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.0 to 12.0 g/dL during the efficacy evaluation period (EEP) was assessed. The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.

Secondary outcomes

  1. Change in Hemoglobin Concentration Between Reference SVP and EEP

    Time frame: Week -4 up to Week 0 and Week 17 up to Week 24

    The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.

  2. Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range

    Time frame: Week 17 up to Week 24

    Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.

  3. Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP

    Time frame: Week 17 up to Week 24

    Median time spent by participants with hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.

  4. Percentage of Participants Requiring Any Dose Adjustment

    Time frame: Week 1 up to Week 16 and Week 17 up to Week 24

    Percentage of participants requiring any adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.

  5. Number of Participants With Red Blood Cell Transfusion During the Study

    Time frame: Week -4 up to Week 52

    Number of participant who underwent red blood cell transfusion during the study was reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

Acronym: CARISMA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 18, 2008
Registry last updated
Apr 6, 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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