LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517413
First received: August 16, 2007
Last updated: March 15, 2011
Last verified: March 2011
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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 May 16, 2013