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MISTRAL Study: A Study of Monthly Subcutaneous Mircera for Maintenance Treatment of Patients With Chronic Kidney Disease on Peritoneal Dialysis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00737477
First received: August 18, 2008
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic kidney disease on peritoneal dialysis. Patients currently receiving maintenance treatment with subcutaneous ESA will receive monthly subcutaneous injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Multi-center Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration within range of 10-12g/dL during Efficacy Evaluation Period (EEP). [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients maintaining all Hb concentrations within range of 10-12g/dL during EEP. [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
  • Percentage of patients maintaining average Hb concentration within range of 10-12g/dL, and with Hb variation <= +/- 1.0g/dL compared to baseline. [ Time Frame: Weeks 16-52 ] [ Designated as safety issue: No ]
  • Mean change in Hb concentration; dose adjustments; RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10-12g/dL [ Time Frame: Weeks 16-52 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: September 2008
Study Completion Date: December 2011
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
s.c. every month (starting dose based on previous ESA therapy).

  Eligibility

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic kidney disease, on peritoneal dialysis for >3 months;
  • chronic renal anemia;
  • continuous s.c. maintenance stable ESA therapy for 4 weeks prior to study start.

Exclusion Criteria:

  • transfusion of red blood cells during previous 8 weeks;
  • poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months;
  • significant acute or chronic bleeding during previous 8 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737477

  Show 52 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00737477     History of Changes
Other Study ID Numbers: ML21421, 2008-001747-18
Study First Received: August 18, 2008
Last Updated: April 18, 2012
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 17, 2013