A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.

NCT00546481 | Completed Phase 3 Results

• 1 other identifier: ML20884
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Hemoglobin Response up to Week 24

  Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb\>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented

  Up to Week 24

Secondary Outcomes (7)

• Mean Change From Baseline in Hemoglobin Concentration at Week 24

  From Baseline (Day 1) to Week 24

• Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24

  Up to Week 24

• Number of Participants Who Received Red Blood Cells Transfusions up to Week 49

  Up to Week 49

• Number of Participants With Any Adverse Events and Serious Adverse Events

  Up to Week 49

• Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24

  From Baseline (Day 1) to Week 24

Study Arms (2)

Correction Phase: CERA

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]

Correction Phase: Epoetin Beta

ACTIVE COMPARATOR

Drug: Epoetin

Interventions

methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] DRUG

0.6 micrograms/kg every 2 weeks

Correction Phase: CERA

Epoetin DRUG

As prescribed, iv, 3 times weekly

Correction Phase: Epoetin Beta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• chronic renal anemia;
• maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before screening, and during screening period.

You may not qualify if:

• previous therapy with epoetin within 8 weeks prior to screening;
• overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
• RBC transfusions within 8 weeks before screening or during screening period;
• active malignant disease except non-melanoma skin cancer.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Gyeonggi-do, 431-070, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 134-701, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, 405-760, South Korea

Location

Unknown Facility

Sungnam, 463-802, South Korea

Location

Related Publications (1)

• Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.

  PMID: 24431909 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator; Erythropoietin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 19, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 19, 2016
• Results First Posted: July 18, 2016

Record last verified: 2016-08

Locations

KR (7)