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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00077597

First received: February 10, 2004

Last updated: June 3, 2013

Last verified: June 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Anemia	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: epoetin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia Chronic Kidney Disease Dialysis

Drug Information available for: Polyethylene Erythropoietin Polyethylene glycol Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	182
Study Start Date:	February 2004
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.4 micrograms/kg iv (starting dose) once every 2 weeks
Active Comparator: 2	Drug: epoetin 3 times a week iv, as prescribed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077597

Show 60 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077597 History of Changes
Other Study ID Numbers:	BA16736
Study First Received:	February 10, 2004
Last Updated:	June 3, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases

Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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