A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients With Chronic Kidney Disease.

Anemia Clinical Trial

Official title:

An Open-label, Multi-center Study to Demonstrate Correction of Anemia and to Assess the Maintenance of Hemoglobin Levels Using Subcutaneous Once Monthly Injections of Mircera in Pre-dialysis Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462384
• Other study ID #: ML20659
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2007
• Last updated: July 19, 2011
• Start date: February 2008
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia 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 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: 36
• Est. completion date: April 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, stage 3 or 4;

• anemia (baseline Hb between 9 and 11g/dL).

Exclusion Criteria:

• previous therapy with ESA within 12 weeks prior to screening;

• overt gastrointestinal bleeding, or bleeding episode necessitating transfusion within 8 weeks before screening;

• red blood cell transfusions within 8 weeks before screening;

• 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
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Estonia,  Finland,  Latvia,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Hb concentration between baseline and evaluation period		Weeks 29 to 36	No
Secondary	Time to achievement of response, and mean time spent in Hb range of 11-13g/dL		Throughout study	No
Secondary	Percentage of patients maintaining Hb concentration of 11-13g/dL throughout evaluation period		Weeks 29-36	No