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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: March 1, 2007
Last updated: May 4, 2016
Last verified: May 2016
This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin 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. every 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 size is 100-500 individuals.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00442793

Beijing, China, 100050
Beijing, China, 10029
Beijing, China, 100853
Chengdu, China, 610072
Guangzhou, China
Guangzhou, China, 510515
Hangzhou, China, 310003
Nanjing, China, 210009
Shanghai, China, 200040
Shanghai, China, 200001
Shanghai, China, 200003
Shanghai, China, 200032
Shanghai, China, 200025
Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: May 4, 2016
Health Authority: China: SFDA

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Epoetin Alfa

ClinicalTrials.gov processed this record on May 26, 2016