A Study of Mircera for the Treatment of Anemia in Dialysis Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

February 10, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Hemoglobin response rate [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Hemoglobin response rate during the first 24 weeks

Change History

Complete list of historical versions of study NCT00077597 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Hb over time, time to target Hb response, incidence of RBC transfusions
Safety: Vital signs, ECG, AEs, laboratory values

Descriptive Information

Brief Title ^ICMJE

A Study of Mircera for the Treatment of Anemia in Dialysis Patients

Official Title ^ICMJE

A Randomized, Open-Label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Brief Summary

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. 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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Anemia

Intervention ^ICMJE

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: epoetin

Study Arms / Comparison Groups

Publications *

Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000.

* 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 ^ICMJE

Completed

Enrollment ^ICMJE

182

Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients >=18 years of age;
chronic renal anemia;
dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of any investigational drug within 4 weeks before screening.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Canada, Czech Republic, Greece, Norway, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, Thailand

Administrative Information

NCT ID ^ICMJE

NCT00077597

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

BA16736

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP