A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia

NCT ID: NCT00605293

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-01-31

Brief Summary

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C.E.R.A

Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta

Intervention Type: DRUG

120, 200 or 360 micrograms iv/month (starting dose)

Epoetin Alfa

Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.

Group Type: ACTIVE_COMPARATOR

Epoetin alfa

Intervention Type: DRUG

As prescribed

Interventions

methoxy polyethylene glycol-epoetin beta

120, 200 or 360 micrograms iv/month (starting dose)

Intervention Type: DRUG

Epoetin alfa

As prescribed

Intervention Type: DRUG

Other Intervention Names

Mircera; C.E.R.A

Eligibility Criteria

Inclusion Criteria

• chronic renal anemia;
• continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
• regular hemodialysis for greater than or equal to (>=) 3 months

Exclusion Criteria

• transfusion of red blood cells during previous 2 months
• poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Badajoz, Badajoz, Spain

Barcelona, Barcelona, Spain

Cáceres, Caceres, Spain

Cádizv, Cadiz, Spain

Castellon, Castellon, Spain

Ciudad Real, Ciudad Real, Spain

Huelva, Huelva, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Marbella, Malaga, Spain

Tudela, Navarre, Spain

Pontevedra, Pontevedra, Spain

Salamanca, Salamanca, Spain

Teruel, Teruel, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Zamora, Zamora, Spain

Zaragoza, Zaragoza, Spain

Countries

Spain

References

Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Reference Type: DERIVED

PMID: 26965694 (View on PubMed)

Other Identifiers

2007-002065-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML21060

Identifier Type: -

Identifier Source: org_study_id