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

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. Identifier: NCT00442793
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: Epoetin beta Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Hb response rate [ Time Frame: Weeks 0-24 ]
  2. Change in Hb concentration between baseline and evaluation period [ Time Frame: Months 4-6 ]

Secondary Outcome Measures :
  1. Hb over time [ Time Frame: Throughout study ]
  2. Time to Hb response [ Time Frame: Throughout study ]
  3. RBC transfusions [ Time Frame: Weeks 0-24 ]
  4. AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ]
  5. Serum concentration of Mircera [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00442793

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

Responsible Party: Hoffmann-La Roche Identifier: NCT00442793     History of Changes
Other Study ID Numbers: ML20680
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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