A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Sponsor study identifier
interventional
182
13 countries
59
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
June 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2004
Actual (reported)February 12, 2004
Actual (reported)June 2006
Actual (reported)June 2006
Actual (reported)Hemoglobin response rate
Weeks 1-24
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Throughout study
0.4 micrograms/kg iv (starting dose) once every 2 weeks
Davis, California, 95616, United States
Lakewood, Colorado, 80260, United States
Atlanta, Georgia, 30342, United States
Augusta, Georgia, 30901, United States
New Orleans, Louisiana, 70112, United States
Boston, Massachusetts, 02115, United States
Springfield, Massachusetts, 01107, United States
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.
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. doi: 10.1053/j.ajkd.2007.08.013.
Clinical Trials
Hoffmann-La Roche
182 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2004
First Posted
February 12, 2004
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Contact the study team to confirm eligibility.
Detroit, Michigan, 48202-2689, United States
Mineola, New York, 11501, United States
New York, New York, 10128, United States
Toledo, Ohio, 43606, United States
Houston, Texas, 77054, United States
Burlington, Vermont, 05401, United States
Norfolk, Virginia, 23507-1901, United States
Curitiba, 81050-090, Brazil
Ribeirão Preto, 14025-170, Brazil
São Paulo, 01307-001, Brazil
São Paulo, 04039-000, Brazil
Calgary, Alberta, T2N 2T9, Canada
Vancouver, British Columbia, V5Z 1M9, Canada
Winnipeg, Manitoba, R3A 1R9, Canada
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Kingston, Ontario, K7L 3N6, Canada
London, Ontario, N6A 5A5, Canada
Toronto, Ontario, M5G 2C4, Canada
Montreal, Quebec, H3A 1A1, Canada
Saskatoon, Saskatchewan, S7K 1N4, Canada
Liberec, 460 63, Czechia
Prague, 169 00, Czechia
Ústí nad Labem, 401 13, Czechia
Alexandroupoli, 68100, Greece
Larissa, 41 110, Greece
Nikaia, 18354, Greece
Thessaloniki, 54629, Greece
Bergen, 5021, Norway
Oslo, 0407, Norway
Gdansk, 80-211, Poland
Gdynia, 81-519, Poland
Krakow, 31-501, Poland
Lodz, 90-153, Poland
Poznan, 60-355, Poland
Szczecin, 70-111, Poland
Wołomin, 05-200, Poland
Wroclaw, 50-417, Poland
Moscow, 123182, Russia
Moscow, 125101, Russia
Moscow, 129110, Russia
Saint Petersburg, 195067, Russia
Saint Petersburg, 197089, Russia
Johannesburg, 2193, South Africa
Soweto, South Africa
Bilbao, 48013, Spain
Santander, 39008, Spain
Karlstad, 65185, Sweden
Lausanne, 1011, Switzerland
Bangkok, 10700, Thailand
Bangkok, Thailand
Chiang Mai, 50200, Thailand
Chon Buri, Thailand
Primary Completion
June 2006
Actual (reported)Study Completion
June 2006
Actual (reported)Last Updated
November 2, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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