A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

NCT00661388 | Completed Phase 3 Results

• 1 other identifier: ML21524
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 9

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. 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)

• Mean Change in Hb Concentration Between Baseline and the Efficacy Evaluation Period

  Mean change in Hb concentration was calculated as the difference between the time adjusted average of Hb during the efficacy evaluation period (EEP \[Week 29 to Week 36\]), and the Hb at Baseline (Week 0). A positive change from baseline indicates improvement.

  From Baseline (Week 0) to EEP (Week 29 to Week 36)

Secondary Outcomes (17)

• Mean Time to Achievement of Response During the EEP

  From Week 29 to Week 36

• The Percentage of Participants Whose Hb Concentrations Remained Within the Target Range of 10.0- 12.0 g/dLThroughout the EEP

  From Week 29 to Week 36

• Mean Time Spent by Participants in the Target Range of 10.0- 12.0 g/dL During the EEP

  From Week 29 to Week 36

• Percentage of Participants Requiring Dose Adjustments During Dose Titration Period and EEP

  Weeks 0 to Week 36

• Number of Participants Who Received Red Blood Cell Transfusions During the Study Period

  Up to Week 52

Study Arms (1)

Continuous erythropoietin receptor activator (C.E.R.A.)

EXPERIMENTAL

Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

sc every month (starting dose 1.2 micrograms/kg)

Continuous erythropoietin receptor activator (C.E.R.A.)

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;
• predialysis stage;
• no ESA therapy during previous 3 months.

You may not qualify if:

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension requiring hospitalization in previous 6 months;
• significant acute or chronic bleeding.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Unknown Facility

Ankara, 06100, Turkey (Türkiye)

Location

Unknown Facility

Denizli, 20100, Turkey (Türkiye)

Location

Unknown Facility

Edirne, 22030, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34000, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34377, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34381, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34390, Turkey (Türkiye)

Location

Unknown Facility

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Unknown Facility

Konya, 42770, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

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

global.trial_information@roche.com

+41 61 6878333

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 11, 2025
• Results First Posted: July 22, 2016

Record last verified: 2016-07

Locations

TU (9)