A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not Receiving ESA Treatment or Dialysis.

Anemia Clinical Trial

Official title:

An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Monthly Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or Dialysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642668
• Other study ID #: ML21348
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2008
• Last updated: January 10, 2013
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: January 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction and/or maintenance of hemoglobin levels in chronic kidney disease patients with renal anemia, who are not currently treated with ESA or on dialysis. Eligible patients will receive monthly subcutaneous injections of Mircera, at an initial recommended dose of 1.2 micrograms/kg. 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: 35
• Est. completion date: September 2010
• Est. primary completion date: September 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;

• no ESA therapy during previous 3 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

• poorly controlled hypertension requiring hospitalization 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]
1.2 micrograms/kg sc monthly (initial recommended dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients maintaining average hemoglobin concentration during Efficacy Evaluation Period (EEP)within target range		Weeks 29-36	No
Secondary	Change in hemoglobin concentration between baseline and EEP		Weeks 1-28	No
Secondary	Proportion of patients maintaining hemoglobin concentrations within range of 10-12g/dL throughout EEP		Weeks 29-36	No
Secondary	Mean time spent in hemoglobin range of 10-12g/dL during EEP		Weeks 29-36	No
Secondary	AEs, lab parameters		Throughout study	No