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

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]; Drug: Epoetin beta

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
  • Beijing, China, 100853
  • Beijing, China, 10029
  • Chengdu, China, 610072
  • Guangzhou, China
  • Guangzhou, China, 510515
  • Hangzhou, China, 310003
  • Nanjing, China, 210009
  • Shanghai, China, 200032
  • Shanghai, China, 200025
  • Shanghai, China, 200040
  • Shanghai, China, 200001
  • Shanghai, China, 200003
• Hong Kong
  • Hong Kong, Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hb response rate	Weeks 0-24
Change in Hb concentration between baseline and evaluation period	Months 4-6

Secondary Outcome Measures

Outcome Measure	Time Frame
Hb over time	Throughout study
Time to Hb response	Throughout study
RBC transfusions	Weeks 0-24
AEs, laboratory parameters, vital signs	Throughout study
Serum concentration of Mircera	Throughout study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: March 1, 2007
• First Submitted That Met QC Criteria: March 1, 2007
• First Posted (Estimate): March 2, 2007

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML20680