MISTRAL Study: A Study of Monthly Subcutaneous Mircera for Maintenance Treatment of Patients With Chronic Kidney Disease on Peritoneal Dialysis.

Anemia Clinical Trial

Official title:

A Single Arm, Open-label, Multi-center Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737477
• Other study ID #: ML21421
• Secondary ID: 2008-001747-18
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2008
• Last updated: April 18, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic kidney disease on peritoneal dialysis. Patients currently receiving maintenance treatment with subcutaneous ESA will receive monthly subcutaneous injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving. 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: 96
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• chronic kidney disease, on peritoneal dialysis for >3 months;

• chronic renal anemia;

• continuous s.c. maintenance stable ESA therapy for 4 weeks prior to study start.

Exclusion Criteria:

• transfusion of red blood cells during previous 8 weeks;

• poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months;

• significant acute or chronic bleeding during previous 8 weeks.

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 Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
s.c. every month (starting dose based on previous ESA therapy).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within range of 10-12g/dL during Efficacy Evaluation Period (EEP).		Weeks 16-24	No
Secondary	Percentage of patients maintaining all Hb concentrations within range of 10-12g/dL during EEP.		Weeks 16-24	No
Secondary	Percentage of patients maintaining average Hb concentration within range of 10-12g/dL, and with Hb variation <= +/- 1.0g/dL compared to baseline.		Weeks 16-52	No
Secondary	Mean change in Hb concentration; dose adjustments; RBC transfusions		Throughout study	No
Secondary	Mean time spent in Hb range of 10-12g/dL		Weeks 16-52	No
Secondary	AEs, laboratory parameters.		Throughout study	No