A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Anemia Clinical Trial

Official title:

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882713
• Other study ID #: ML21797
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2009
• Last updated: September 19, 2012
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia.Patients will receive subcutaneous Mircera at a starting dose of 120 or 200 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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: 202
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;

• continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• active malignant disease (except non-melanoma skin cancer).

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]
Subcutaneous injection every 4 weeks (starting dose of 120 or 200 micrograms, 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

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients maintaining average Hb concentration within target range during Efficacy Evaluation period (EEP)		Weeks 17-24	No
Secondary	Change in hemoglobin concentration between reference (SVP) and the EEP		Weeks 1-24	No
Secondary	Proportion of patients maintaining hemoglobin concentration within the hemoglobin range 10.5-12.5g/dL throughout the EEP		Weeks 17-24	No
Secondary	Mean time spent in hemoglobin range of 10.5-12.5g/dL		Every 2 weeks	No
Secondary	Adverse events, laboratory parameters		At planned visits, to week 48	No