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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 17, 2008

Last Updated Date

May 13, 2009

Start Date ^†

July 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699348 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Anemia

Intervention ^†

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

300

Estimated Completion Date

May 2010

Primary Completion Date

Eligibility 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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699348

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

2007-005799-15

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.