A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00364832
First received: August 15, 2006
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will determine the appropriate dose and frequency of administration o f sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on s tudy 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 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 Subcutaneous Mircera in Dialysis 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.\nVital signs, adverse events, laboratory values\n [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: October 2001
Study Completion Date: April 2006
Primary Completion Date: April 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;
  • on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
  • receiving sc epoetin alfa or beta for at least 3 months 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 preceding 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: NCT00364832

Locations
United States, California
Los Angeles, California, United States, 90073
San Jose, California, United States, 95116-1906
United States, Massachusetts
Boston, Massachusetts, United States, 02130
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
Houston, Texas, United States, 77030
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Germany
Berlin, Germany, 10625
Mannheim, Germany, 68167
Villingen-schwenningen, Germany, 78054
Wiesloch, Germany, 69168
Italy
Bari, Italy, 70124
Bergamo, Italy, 24128
Lecco, Italy, 23900
Lodi, Italy, 26900
Milano, Italy, 20122
Modena, Italy, 41100
Pavia, Italy, 27100
Vicenza, Italy, 36100
Spain
Barcelona, Spain, 08036
Madrid, Spain, 28046
Madrid, Spain, 28007
Malaga, Spain, 29010
Santander, Spain, 39008
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00364832     History of Changes
Other Study ID Numbers: BA16286
Study First Received: August 15, 2006
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014