An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis (IMPACT)

Roche

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Study type: Observational

Funder types: Industry

Identifiers

NCT02238080

ML22556

Details and patient eligibility

About

This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CKD participants undergoing dialysis
• Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
• Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Exclusion criteria

• Conditions known to cause inadequate response to ESA treatment
• Anemia other than symptomatic anemia associated with CKD

Trial design

197 participants in 1 patient group

Methoxy Polyethylene Glycol-Epoetin Beta

Description:

Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.

Treatment:

Drug: Methoxy Polyethylene Glycol-Epoetin Beta