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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cavite, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

methoxy polyethylene glycol-epoetin beta [Mircera]

Drug

sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks

Primary outcomes

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

Time frame: 24 weeks after first dose, through week 25

Secondary outcomes

>=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

Time frame: At end of 24 weeks treatment

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jun 17, 2009
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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