San Diego, California 92103

  • Anemia

Purpose:

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.


Criteria:

Inclusion Criteria: - adult patients >=18 years of age; - chronic renal anemia; - on dialysis therapy for at least 12 weeks before screening; - receiving IV 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.


Study is Available At:


Original ID:

BA16739


NCT ID:

NCT00077610


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

673


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:February 2004
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 1, 2015
First Received Date:February 10, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:AEs, laboratory parameters, vital signs.
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:RBC transfusions
Time Frame:Weeks 1-36
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of patients maintaining average Hb concentration within +/- 1g/dL of average Hb concentration
Time Frame:Weeks 29-36
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in hemoglobin concentration
Time Frame:Weeks 1-36
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:epoetin alfa or beta
Description:iv 3 times weekly, as prescribed
Arm Name:3
Intervention Type:Drug
Name:methoxy polyethylene glycol-epoetin beta [Mircera]
Description:30, 50 or 90 micrograms iv (starting dose) every 2 weeks
Arm Name:1
Intervention Type:Drug
Name:methoxy polyethylene-glycol epoetin beta [Mircera]
Description:30, 50 or 90 micrograms iv (starting dose) every 4 weeks
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Study Arm Type:Experimental
Arm Name:2
Study Arm Type:Active Comparator
Arm Name:3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.