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A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773331
First Posted: October 16, 2008
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition Intervention Phase
Anemia Drug: epoetin beta Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels 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 concentration between baseline and the EEP [ Time Frame: Week 20-28 ]

Secondary Outcome Measures:
  • Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP. [ Time Frame: Weeks 1-28 ]
  • Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP. [ Time Frame: Weeks 1-28 ]
  • Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG. [ Time Frame: Throughout study ]

Enrollment: 281
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms every 4 weeks
Active Comparator: 2 Drug: epoetin beta
As prescribed

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female patients, >=18 years of age;
  • chronic renal anemia;
  • Hb concentration 10.0 - 12.0 g/dL during the screening period;
  • continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.

Exclusion Criteria:

  • blood transfusion within the previous 8 weeks;
  • poorly controlled hypertension;
  • significant or acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773331


Locations
China
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100050
Beijing, China, 100083
Beijing, China, 100853
Chengdu, China, 610072
Guangzhou, China, 510515
Guangzhou, China
Hangzhou, China, 310003
Nanjing, China, 210009
Nanjing, China, 210036
Shanghai, China, 200001
Shanghai, China, 200025
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773331     History of Changes
Other Study ID Numbers: ML21904
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics