An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

Roche

Status: Completed

Conditions: Kidney Disease, Chronic

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT02547454

ML22069

Details and patient eligibility

About

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Enrollment: 393 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged > 18 years with CKD
• Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Exclusion criteria

• Non-renal anemia
• Pregnancy and breast-feeding
• Uncontrolled hypertension
• Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
• Administration of any other study drug within 30 days prior to study enrollment

Trial design

393 participants in 1 patient group

CKD participants treated with Mircera

Description:

Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta