A Study of Intravenous Mircera for the Maintenance Treatment of Hemodialysis Patients With Chronic Renal Anemia

Anemia Clinical Trial

Official title:

An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605293
• Other study ID #: ML21060
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2008
• Last updated: October 7, 2013
• Start date: December 2007
• Est. completion date: February 2010

Study information

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

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of monthly administration of intravenous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients 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 time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• 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 iv maintenance epoetin alfa therapy, with the same dosing interval during the 2 months before screening;

• regular hemodialysis for >=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;

• significant acute or chronic bleeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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/month (starting dose)
• Epoetin alfa
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within +/- 1g/dL of reference Hb, and between 10-12g/dL during evaluation period.		Weeks 17-24	No
Secondary	Change in Hb concentration, and percentage of patients maintaining Hb concentration in 10-12g/dL range.		Weeks 17-24	No
Secondary	Mean time in 10-12g/dL range; percentage of patients needing dose adjustments; incidence of RBC transfusions.		Throughout study	No
Secondary	AEs, laboratory parameters.		Throughout study	No