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A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00546481
First received: October 18, 2007
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  Purpose

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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]
Drug: Epoetin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study of the Effect of Intravenous Mircera on the Hemoglobin Response Rate in Patients With Chronic Kidney Disease Who Are on Dialysis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hb response rate (increase in Hb >=1g/dL, and Hb concentration >=11g/dL, without RBC transfusion) [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hb values, change from baseline, time to Hb response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs, ECGs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: November 2007
Study Completion Date: April 2010
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg every 2 weeks
Active Comparator: 2 Drug: Epoetin
As prescribed, iv, 3 times weekly

  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;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.

Exclusion Criteria:

  • previous therapy with epoetin within 8 weeks prior to screening;
  • overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
  • RBC transfusions within 8 weeks before screening or during screening period;
  • active malignant disease except non-melanoma skin cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546481

Locations
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 431-070
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 134-701
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 405-760
Sungnam, Korea, Republic of, 463-802
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: NCT00546481     History of Changes
Other Study ID Numbers: ML20884
Study First Received: October 18, 2007
Last Updated: September 23, 2010
Health Authority: Korea: KFDA

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013