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

NCT ID: NCT00517413

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-05-31

Brief 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.

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C.E.R.A

Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta \[Mircera\]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.

Group Type: EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type: DRUG

120, 200 or 360 micrograms sc or iv monthly, starting dose

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]

120, 200 or 360 micrograms sc or iv monthly, starting dose

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Buenos Aires, , Argentina

Córdoba, , Argentina

Santa Fe, , Argentina

Aracajú, , Brazil

Curitiba, , Brazil

Fortaleza, , Brazil

São Paulo, , Brazil

Santiago, , Chile

Bogotá, , Colombia

Bogotá, , Colombia

Quito, , Ecuador

Cuernavaca, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Monterrey, , Mexico

Callao, , Peru

Callao, , Peru

Lima, , Peru

Montevideo, , Uruguay

Montevideo, , Uruguay

Caracas, , Venezuela

Caracas, , Venezuela

Maracaibo, , Venezuela

Countries

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

References

Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Reference Type: DERIVED

PMID: 26965694 (View on PubMed)

Other Identifiers

ML20881

Identifier Type: -

Identifier Source: org_study_id