A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00442793
First received: March 1, 2007
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 2 arm study will compare the effect on hemoglobin response of Mircera and e poetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. e very 2 weeks) or epoetin beta (3 times weekly, according to approved labelling).

The anticipated time on study treatment is 3-12 months, and the target sample s ize 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hb response rate [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • Change in Hb concentration between baseline and evaluation period [ Time Frame: Months 4-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hb over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Time to Hb response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Serum concentration of Mircera [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: May 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.4 micrograms/kg iv every 2 weeks
Active Comparator: 2 Drug: Epoetin beta
As prescribed, 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 requiring dialysis;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
  • adequate iron status.

Exclusion Criteria:

  • previous epoetin treatment within 8 weeks prior to screening;
  • failing renal graft in place;
  • bleeding episode necessitating transfusion within 8 weeks prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.
  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: NCT00442793

Locations
China
Beijing, China, 100853
Beijing, China, 100050
Beijing, China, 100029
Chengdu, China, 610072
Guangzhou, China, 510515
Guangzhou, China, 510080
Hangzhou, China, 310003
Nanjing, China, 210009
Shanghai, China, 200040
Shanghai, China, 200001
Shanghai, China, 200025
Shanghai, China, 200032
Shanghai, China, 200003
Hong Kong
Hong Kong, Hong Kong
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: NCT00442793     History of Changes
Other Study ID Numbers: ML20680
Study First Received: March 1, 2007
Last Updated: August 26, 2014
Health Authority: China: SFDA

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

ClinicalTrials.gov processed this record on September 16, 2014