A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia - Tabular View

Tracking Information

First Received Date ^ICMJE

October 24, 2002

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in hemoglobin from baseline over time under constant dosing regimen [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy: Change in hemoglobin from baseline over time under constant dosing regimen

Change History

Complete list of historical versions of study NCT00048035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Change in hematocrit from baseline over time under constant dosing regimen
Safety: Vital signs, adverse events, laboratory values

Descriptive Information

Brief Title ^ICMJE

A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

Official Title ^ICMJE

A Randomized, Open-Label Study of Dose Conversion Factors for Maintenance Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Brief Summary

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Detailed Description

Study Phase

Phase II

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]

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

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients >=18 years of age;
chronic renal anemia;
on hemodialysis therapy for at least 3 months;
receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment 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

Administrative Information

NCT ID ^ICMJE

NCT00048035

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

BA16285

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