A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease Not Treated With ESA or on Dialysis.

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559637
• Other study ID #: ML20888
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2007
• Last updated: March 15, 2011
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul Erhlich Institut
• 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 treated with ESA and not on dialysis. Eligible patients will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 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: 185
• Est. completion date: January 2011
• Est. primary 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;

• baseline Hb between 9 and 11g/dL.

Exclusion Criteria:

• prior ESA therapy during previous 3 months;

• acute or chronic bleeding requiring therapy during previous 2 months;

• transfusion of red blood cells during previous 2 months;

• 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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining Hb within range during evaluation period; change in Hb from baseline to evaluation period; mean time spent in target range		Weeks 29-36	No
Secondary	Incidence of RBC transfusions		Throughout study	No
Secondary	AEs, laboratory parameters		Throughout study	No