A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048035
First received: October 24, 2002
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will determine the appropriate dose and frequency of administration o f iv Mircera maintenance therapy in hemodialysis patients with chronic renal ane mia who were previously receiving iv epoetin. The anticipated time on study trea tment is 3-12 months and the target sample size is <100 individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 2

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 Dose Conversion Factors for Maintenance Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in hemoglobin from baseline over time under constant dosing regimen\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: February 2002
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Experimental: 3 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Experimental: 4 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Experimental: 5 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration
Experimental: 6 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of iv administration

  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;
  • on hemodialysis therapy for at least 3 months;
  • receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
  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: NCT00048035

Locations
United States, Alabama
Birmingham, Alabama, United States, 35211
United States, California
Los Angeles, California, United States, 90095
United States, Illinois
Maywood, Illinois, United States, 60153
United States, Kentucky
Louisville, Kentucky, United States, 40202-1718
United States, Michigan
Detroit, Michigan, United States, 48236
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Paterson, New Jersey, United States, 07503
United States, New York
Brooklyn, New York, United States, 11203
Mineola, New York, United States, 11501
New York, New York, United States, 10128
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048035     History of Changes
Other Study ID Numbers: BA16285
Study First Received: October 24, 2002
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 14, 2014