A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

Phase 4

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

• Registration Number: NCT00922610
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• adult patients, >=18 years of age;
• chronic kidney disease;
• anemia (Hb >8 and <11 g/dL);
• regular dialysis or predialysis, not treated with ESA.

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Exclusion Criteria

• transfusion of red blood cells during previous 8 weeks;
• poorly controlled hypertension;
• overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
• active malignant disease (except melanoma of skin).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-epoetin beta [Mircera]	-

Primary Outcome Measures

Name	Time	Method
Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients	24 weeks after first dose, through week 25

Secondary Outcome Measures

Name	Time	Method
>=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments	At end of 24 weeks treatment