A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

Anemia Clinical Trial

Official title:

An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00680563
• Other study ID #: ML21467
• Status: Terminated
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: November 4, 2013
• Start date: April 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections 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: Terminated
• Enrollment: 4
• Est. completion date: January 2010
• Est. primary completion date: January 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;

• adequate iron status;

• rapid chronic kidney disease progression.

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]
sc every month (starting dose 1.2 micrograms/kg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Costa Rica,  Ecuador,  Guatemala,  Panama,  Peru,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).		Week 32	No
Secondary	Time to achievement of response		Throughout study	No
Secondary	Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL		Throughout study	No
Secondary	Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL		Throughout study	No
Secondary	Mean time spent in Hb range of 10.0 - 12.0g/dL		Throughout study	No
Secondary	Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.		Throughout study	No