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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00699348
First received: June 17, 2008
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Anemia
Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Hemoglobin Concentration Between Reference SVP and EEP [ Time Frame: Week -4 up to Week 0 and Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Median Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP [ Time Frame: Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Requiring Any Dose Adjustment [ Time Frame: Week 1 up to Week 16 and Week 17 up to Week 24 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Red Blood Cell Transfusion During the Study [ Time Frame: Week -4 up to Week 52 ] [ Designated as safety issue: No ]
    Number of participant who underwent red blood cell transfusion during the study was reported.


Enrollment: 351
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C.E.R.A. Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
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 Name: Mircera

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699348

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00699348     History of Changes
Other Study ID Numbers: ML21438  2007-005799-15 
Study First Received: June 17, 2008
Results First Received: March 8, 2016
Last Updated: March 8, 2016
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2016