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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Anemia	Drug: epoetin; Drug: methoxy polyethylene glycol-epoetin beta [Mircera]	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	182 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	February 2004
Actual Primary Completion Date :	June 2006
Actual Study Completion Date :	June 2006

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Hemoglobin response rate [ Time Frame: Weeks 1-24 ]

Secondary Outcome Measures :

1. Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n [ Time Frame: Throughout study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 59 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 12, 2004
Last Update Posted:	November 2, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:

Anemia; Hematologic Diseases; Epoetin Alfa; Hematinics