LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517413
First received: August 16, 2007
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Intravenous or Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Hb concentration, and percentage patients maintaining Hb concentration in target range throughout evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 165
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc or iv monthly, starting dose

  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;
  • hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
  • stable maintenance epoetin alfa therapy for past 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
  • acute or chronic bleeding during previous 2 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517413

Locations
Argentina
Buenos Aires, Argentina, 1155
Buenos Aires, Argentina, 1663
Buenos Aires, Argentina, 1824
Buenos Aires, Argentina, 1437
Córdoba, Argentina, 5000
Santa Fe, Argentina, 3000
Brazil
Aracajú, Brazil, 49055-210
Curitiba, Brazil, 80050-350
Fortaleza, Brazil, 60430-370
Sao Paulo, Brazil, 05624-000
Chile
Santiago, Chile, 056
Colombia
Bogota, Colombia, 0
Bogotá, Colombia
Ecuador
Quito, Ecuador, 2569
Mexico
Cuernavaca, Mexico, 62448
Mexico City, Mexico, 14000
Mexico City, Mexico, 14050
Mexico City, Mexico, 03900
Mexico City, Mexico, 11520
Monterrey, Mexico, 64710
Peru
Callao, Peru, C 01
Callao, Peru, C01
Lima, Peru, L13
Uruguay
Montevideo, Uruguay, 11600
Montevideo, Uruguay, 11800
Venezuela
Caracas, Venezuela, 1060
Caracas, Venezuela, 1062
Maracaibo, Venezuela, 4002
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517413     History of Changes
Other Study ID Numbers: ML20881
Study First Received: August 16, 2007
Last Updated: March 15, 2011
Health Authority: Ecuador: Ministry of Health

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014