A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

Anemia Clinical Trial

Official title:

An Open Label Study to Assess the Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anaemia Who Are Currently Receiving Epoetin Alfa or Beta.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576303
• Other study ID #: ML20977
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: October 14, 2011
• Start date: February 2008
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Agency of Drug Quality Control
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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: 200
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic renal anemia;

• hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;

• continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;

• significant acute or chronic bleeding such as overt gastrointestinal bleeding;

• hemolysis;

• folic acid and vitamin B12 deficiency.

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
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

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

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/L during evaluation period.		Weeks 17-24	No
Secondary	Change in Hb concentration over evaluation period		Weeks 17-24	No
Secondary	Percentage of patients maintaining Hb concentration in target range throughout evaluation period.		Weeks 17-24	No
Secondary	Mean time spent in Hb target range; mean number of months/subject requiring dose adjustments; incidence of RBC transfusions.		Throughout study	No