At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 673 enrolled

Drug / intervention

Epoetin alfa or beta +2 moredrug

Likely dose

RO0503821 60, 100, or 180 mcg IV once every 2 weeks OR 120, 200, or 360 mcg IV once every 4 weeks (starting doses, adjusted per protocol)AI-extracted

Key inclusion· 4

✓Age ≥18 years
✓Chronic renal anemia diagnosis
✓On dialysis therapy for at least 12 weeks prior to screening
✓Receiving IV epoetin for at least 8 weeks prior to screening

Key exclusion· 2

✕Pregnancy, breastfeeding, or unreliable contraception
✕Investigational drug within 4 weeks before screening or during study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00077610

NCT00077610Phase 3Completed

Compare CT.gov

A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.

Hoffmann-La Roche·interventional·Posted Feb 13, 2004·Updated Jan 13, 2017

In Brief

A Phase 3 clinical trial evaluating Epoetin alfa or beta, RO0503821 (1x/2 Weeks), and 1 other intervention for Anemia. Completed, enrolled 673 participants across 99 sites in 8 countries.

Detailed Summary

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnemia

CountriesCanada, France, Germany, Italy, Norway, Spain, Switzerland, United States

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2004

First PostedFeb 2004

Primary CompletionAug 2005

TodayJul 2026

First PostedFeb 13, 2004

Enrollment StartFeb 1, 2004

Primary CompletionAug 1, 2005

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 22.4 years ago

Interventions

Epoetin alfa or betadrug

intravenously 3 times weekly for 52 weeks, as prescribed

RO0503821 (1x/2 Weeks)drug

60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks.

RO0503821 (1x/4 Weeks)drug

120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks.