A Study of MIRCERA in Participants With Chronic Kidney Disease Stage 3-4 and Not on Dialysis

Roche

Status: Completed

Conditions: Anemia

Treatments: Other: MIRCERA

Study type: Observational

Funder types: Industry

Identifiers

NCT02567188

ML22439

Details and patient eligibility

About

An observational, longitudinal, multi-center, non-interventional study in participants with chronic kidney disease (CKD) stage 3-4, assessed by Modification of Diet in Renal Disease (MDRD) to collect data regarding safety and efficacy in participants with pre-dialysis situation who are treated with MIRCERA in normal clinical environment.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants above 18 years of age
• Pre-dialysis participants with CKD stage 3-4 treated with MIRCERA and continue in the pre-dialysis state for the whole study period
• Estimated glomerular filteration rate (e-GFR) between 15-60 milliliter per minute (mL/min) (calculated)

Exclusion criteria

• Participants involved in interventional trials
• Participants with life expectancy less than 1 year
• Active malignancy
• Planned living kidney transplant within 6 months.

Trial design

144 participants in 1 patient group

Cohort of CKD Participants

Description:

Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.

Treatment:

Other: MIRCERA