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A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or on Dialysis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00559637
First received: November 15, 2007
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in patients with chronic kidney disease who are not treated with ESA and not on dialysis. Eligible patients will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kg. 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: An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Correction of Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Currently Treated With ESA and Not on 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 Hb within range during evaluation period; change in Hb from baseline to evaluation period; mean time spent in target range [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 185
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
1.2 micrograms/kg sc monthly, starting dose

  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 renal anemia;
  • baseline Hb between 9 and 11g/dL.

Exclusion Criteria:

  • prior ESA therapy during previous 3 months;
  • acute or chronic bleeding requiring therapy during previous 2 months;
  • transfusion of red blood cells during previous 2 months;
  • active malignant disease (except non-melanoma skin cancer).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559637

  Show 50 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: NCT00559637     History of Changes
Other Study ID Numbers: ML20888
Study First Received: November 15, 2007
Last Updated: March 15, 2011
Health Authority: Germany: Paul Erhlich Institut

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 May 21, 2013