A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.

Anemia Clinical Trial

Official title:

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous MIRCERA for the Treatment of Chronic Renal Anaemia in Dialysis Patients Not Currently Treated With ESA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737711
• Other study ID #: ML21822
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2008
• Last updated: December 1, 2015
• Start date: July 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. 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: 189
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male or female patients, >=18 years of age;

• chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);

• no prior erythropoietin stimulating agent (ESA) therapy.

Exclusion Criteria:

• blood transfusion within the previous 4 weeks;

• poorly controlled hypertension;

• significant acute or chronic bleeding;

• active malignant disease;

• congestive heart failure (NYHA Class IV).

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]
iv 0.6 micrograms/kg every 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Hb concentration from baseline to last visit		Week 16	No
Secondary	Time to achievement of response (Hb target range 10.0g/dL - 12g/dL); percentage of patients with average Hb concentration between 10.0g/dL and 12.0g/dL during that last 4 weeks of treatment.		Week 16	No
Secondary	Mean time spent in the Hb range 10.0g/dL - 12.0g/dL during the last 4 weeks of treatment.		Week 16	No
Secondary	Incidence of AEs, SAEs and deaths; vital signs, laboratory parameters, ECG.		Throughout study	No