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

Tracking Information

First Received Date ^ICMJE

April 13, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in hemoglobin concentration [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Change in hemoglobin concentration between the baseline and evaluation periods

Change History

Complete list of historical versions of study NCT00081484 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
RBC transfusions [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Patients within 1 g/dL of their average baseline Hb concentration, RBC transfusions
Safety: Vital signs, AEs, laboratory values

Descriptive Information

Brief Title ^ICMJE

A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Official Title ^ICMJE

A Randomized, Open-Label Study of the Effect of Maintenance Mircera Administered With Pre-Filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Brief Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months 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 alfa or beta

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 ^ICMJE

Completed

Enrollment ^ICMJE

336

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients >=18 years of age;
chronic renal anemia;
on dialysis therapy for at least 12 weeks before screening;
receiving iv or sc epoetin for at least 8 weeks before screening.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of another investigational drug within 4 weeks before screening, or during the study period.

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, Canada, France, Germany, Italy, Poland, Portugal, Puerto Rico, Spain, Taiwan, Thailand, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00081484

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

BA17284

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