An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

NCT ID: NCT01695746

Last Updated: 2016-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-11-30

Brief Summary

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

Conditions

Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

C.E.R.A.

Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.

C.E.R.A.

Intervention Type: DRUG

Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.

Interventions

C.E.R.A.

Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients, 18 to 65 years of age, inclusive
• Patients with stage III-IV chronic kidney disease not on dialysis
• Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
• Adequate iron status as judged by the treating physician

Exclusion Criteria

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
• Clinically significant concomitant disease or disorder as defined by protocol
• Clinical suspicion of pure red cell aplasia (PRCA)
• Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
• Transfusion of red blood cells in the previous 2 months
• Pregnant women
• Contraindications for Mircera according to local prescribing information or as judged by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Bhubaneswar, , India

Hyderabad, , India

Mumbai, , India

Mumbai, , India

Vadodara, , India

Vellore, , India

Countries

India

Other Identifiers

ML25476

Identifier Type: -

Identifier Source: org_study_id