A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048048
First received: October 24, 2002
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy and safety of different subcutaneous start ing doses and dosing frequencies of Mircera in anemic patients with chronic kidn ey disease not yet on dialysis. The anticipated time on study treatment 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 the Effect of Different Dosing Intervals of Subcutaneous Mircera on Hemoglobin Level/Correction in Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hemoglobin levels\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematocrit, reticulocyte count. Vital signs, adverse events, laboratory values\n\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: March 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (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 sc administration
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 3 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 4 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 5 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 6 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 7 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 8 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: 9 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc 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;
  • not receiving renal replacement therapy.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of any investigational drug within 30 days preceding the screening visit and during the run-in 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: NCT00048048

Locations
United States, Alabama
Birmingham, Alabama, United States, 35211
United States, California
San Diego, California, United States, 92103-8342
United States, Michigan
Detroit, Michigan, United States, 48202-2689
Detroit, Michigan, United States, 48236
United States, Nevada
Las Vegas, Nevada, United States, 89106
Reno, Nevada, United States, 89434
United States, New York
Mineola, New York, United States, 11501
United States, Oregon
Portland, Oregon, United States, 97201-2940
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
France
Colmar, France, 68024
Paris, France, 75018
Paris, France, 75475
Mexico
Mexico City, Mexico, 14000
Monterrey, Mexico, 64710
Poland
Gdansk, Poland, 80-211
Krakow, Poland, 31-501
Wroclaw, Poland, 50-417
United Kingdom
Belfast, United Kingdom, BT9 7LJ
London, United Kingdom, SE22 8PT
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: NCT00048048     History of Changes
Other Study ID Numbers: BA16528
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 18, 2014