CARISMA Study: A Study of Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

Anemia Clinical Trial

Official title:

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699348
• Other study ID #: ML21438
• Secondary ID: 2007-005799-15
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: October 7, 2013
• Start date: July 2008
• Est. completion date: July 2010

Study information

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

Clinical Trial Summary

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10-12g/dL. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: July 2010
• Est. primary completion date: July 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;

• continuous iv maintenance ESA treatment during previous month;

• regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months;

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

• 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

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
i.v. every month (starting dose based on previous ESA therapy).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP)		Weeks 17-24	No
Secondary	Change in Hb concentration		Between reference and EEP	No
Secondary	Proportion of patients maintaining Hb concentration within the target range		Weeks 17-24	No
Secondary	Median time spent in Hb target range		Throughout study	No
Secondary	Proportion of patients requiring dose adjustments; incidence of RBC transfusions		Weeks 0-24	No