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

Anemia Clinical Trial

Official title:

MIRCEA in ESRD A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642850
• Other study ID #: ML21040
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: October 7, 2013
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic:SUKL
• Study type: Interventional

Clinical Trial 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 patients with chronic renal anemia. Patients 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia;

• continuous stable iv 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 requiring hospitalization or interruption of erythropoietin treatment in previous 6 months;

• significant acute or chronic bleeding.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv monthly (starting dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% patients maintaining average Hb conc. within the target range during the Efficacy Evaluation Period (EEP)		Weeks 17-24	No
Secondary	Change in Hb conc.		Between reference and EEP	No
Secondary	% patients maintaining Hb within target range		Weeks 17-24	No
Secondary	% patients requiring dose adjustments; incidence of RBC transfusions		Weeks 1-24	No
Secondary	AEs, lab parameters		Throughout study	No