STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

NCT ID: NCT00642850

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-07-31

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

120, 200 or 360 micrograms iv monthly (starting dose)

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]

120, 200 or 360 micrograms iv monthly (starting dose)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic renal anemia;
• Continuous stable intravenous maintenance epoetin therapy during previous month;
• Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria

• Transfusion of red blood cells during previous 2 months;
• Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
• Significant acute or chronic bleeding.

• 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

Brno, , Czechia

Český Krumlov, , Czechia

Děčín, , Czechia

Havířov, , Czechia

Hradec Králové, , Czechia

Jihlava, , Czechia

Karlovy Vary, , Czechia

Kolin III, , Czechia

Liberec, , Czechia

Nový Jičín, , Czechia

Olomouc, , Czechia

Ostrava, , Czechia

Písek, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Strakonice, , Czechia

Šumperk, , Czechia

Tábor, , Czechia

Teplice, , Czechia

Třebíč, , Czechia

Ústí nad Labem, , Czechia

Znojmo, , Czechia

Countries

Czechia

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

ML21040

Identifier Type: -

Identifier Source: org_study_id