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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517413
• Other study ID #: ML20881
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2007
• Last updated: March 15, 2011
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ecuador: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc or iv monthly, starting dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Ecuador,  Mexico,  Peru,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period		Weeks 17-24	No
Secondary	Change in Hb concentration, and percentage patients maintaining Hb concentration in target range throughout evaluation period		Weeks 17-24	No
Secondary	Mean time in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions		Throughout study	No
Secondary	AEs, laboratory parameters		Throughout study	No