A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.
NCT ID: NCT00364832
Last Updated: 2016-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
137 participants
INTERVENTIONAL
2001-10-31
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A (0.4/150, 1x/ Week)
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort B (0.4/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort C (0.4/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort D (0.8/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort E (0.8/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort F (0.8/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort G (1.2/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort H (1.2/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Cohort I (1.2/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Interventions
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methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
* receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.
Exclusion Criteria
* use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
San Jose, California, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Houston, Texas, United States
Morgantown, West Virginia, United States
Berlin, , Germany
Mannheim, , Germany
Villingen-Schwenningen, , Germany
Wiesloch, , Germany
Bari, , Italy
Bergamo, , Italy
Lecco, , Italy
Lodi, , Italy
Milan, , Italy
Modena, , Italy
Pavia, , Italy
Vicenza, , Italy
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Locatelli F, Villa G, de Francisco AL, Albertazzi A, Adrogue HJ, Dougherty FC, Beyer U; BA16286 Study Investigators. Effect of a continuous erythropoietin receptor activator (C.E.R.A.) on stable haemoglobin in patients with CKD on dialysis: once monthly administration. Curr Med Res Opin. 2007 May;23(5):969-79. doi: 10.1185/030079907x182103.
Other Identifiers
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BA16286
Identifier Type: -
Identifier Source: org_study_id