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

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: methoxy polyethylene glycol-epoetin beta [Mircera]	Phase III

MedlinePlus related topics:

Anemia Dialysis Kidney Failure

ChemIDplus related topics:

Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Single Arm, Open Label Study to 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 Anaemia

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients maintaining average Hb concentration within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Hb concentration [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
Proportion of patients maintaining Hb concentration within the target range [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Median time spent in Hb target range [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Proportion of patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Estimated Study Completion Date:	January 2010

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699348

Contacts


Contact: Please reference Study ID Number: RLI_ML21438	973-235-5000

Contact: or	800-526-6367 (FOR US ONLY)

Show 80 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21438, 2007-005799-15
First Received:	June 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00699348
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Epoetin Alfa

Hematologic Diseases

Anemia

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00699348