A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients.

Anemia Clinical Trial

Official title:

An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576628
• Other study ID #: ML20978
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: June 15, 2011
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: June 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 subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting 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: 126
• Est. completion date: January 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, with no need for dialysis expected in next 3 months;

• adequate iron status.

Exclusion Criteria:

• previous epoetin therapy within 12 weeks prior to treatment;

• transfusion of red blood cells during 2 months prior to screening;

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

• hemolysis;

• folic acid and vitamin B 12 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

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg sc monthly

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	Change in Hb concentration between screening and evaluation period		Weeks 29-36	No
Secondary	Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period.		Weeks 29-36	No
Secondary	Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions.		Throughout study	No
Secondary	AEs, laboratory parameters.		Throughout study	No