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LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This study is currently recruiting participants.
Verified by Hoffmann-La Roche, April 2009
First Received: August 16, 2007   Last Updated: April 15, 2009   History of Changes
Sponsored by: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517413
  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 III

MedlinePlus related topics: Anemia
Drug Information available for: Epoetin beta
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 200
Study Start Date: October 2007
Estimated Study Completion Date: April 2010
Arms Assigned Interventions
1: Experimental 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

Contacts
Contact: Please reference Study ID Number: ML20881 973-235-5000
Contact: or 800-526-6367 (FOR US ONLY)

Locations
Argentina
Active, not recruiting
BUENOS AIRES, Argentina, 1155
Active, not recruiting
BUENOS AIRES, Argentina, 1663
Active, not recruiting
SANTA FE, Argentina, 3000
Active, not recruiting
BUENOS AIRES, Argentina, 1437
Recruiting
CÓRDOBA, Argentina, 5000
Recruiting
BUENOS AIRES, Argentina, 1824
Brazil
Recruiting
CURITIBA, Brazil, 80050-350
Recruiting
SAO PAULO, Brazil, 05624-000
Recruiting
ARACAJÚ, Brazil, 49055-210
Recruiting
FORTALEZA, Brazil, 60430-370
Chile
Active, not recruiting
SANTIAGO, Chile, 056
Colombia
Terminated
BOGOTA, Colombia, 0
Active, not recruiting
BOGOTÁ, Colombia
Ecuador
Active, not recruiting
QUITO, Ecuador, 2569
Mexico
Active, not recruiting
CUERNAVACA, Mexico, 62448
Active, not recruiting
MEXICO CITY, Mexico, 14000
Active, not recruiting
MEXICO CITY, Mexico, 14050
Active, not recruiting
MEXICO CITY, Mexico, 03900
Active, not recruiting
MONTERREY, Mexico, 64710
Active, not recruiting
MEXICO CITY, Mexico, 11520
Peru
Active, not recruiting
CALLAO, Peru, C 01
Active, not recruiting
CALLAO, Peru, C01
Active, not recruiting
LIMA, Peru, L13
Uruguay
Active, not recruiting
MONTEVIDEO, Uruguay, 11600
Recruiting
MONTEVIDEO, Uruguay, 11800
Venezuela
Active, not recruiting
MARACAIBO, Venezuela, 4002
Active, not recruiting
CARACAS, Venezuela, 1062
Active, not recruiting
CARACAS, Venezuela, 1060
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers: ML20881
Study First Received: August 16, 2007
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00517413     History of Changes
Health Authority: Ecuador: Ministry of Health

Study placed in the following topic categories:
Epoetin Alfa
Hematologic Diseases
Anemia

Additional relevant MeSH terms:
Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on May 07, 2009



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