A Study to Assess Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Participants Not in Dialysis Treated With Methoxy Polyethylene Glycol-Epoetin Beta (COMETE)

Roche

Status: Completed

Conditions: Renal Anemia of Chronic Kidney Disease

Treatments: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Study type: Observational

Funder types: Industry

Identifiers

NCT01756612

ML28145

Details and patient eligibility

About

This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta treatment.

Enrollment: 551 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with chronic kidney disease not on dialysis
• Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study
• Hemoglobin level less then (<)10 grams per deciliter (g/dL) at inclusion
• Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start

Exclusion criteria

• Functional renal transplant
• Current participation in a clinical trial in anemia due to chronic kidney disease

Trial design

551 participants in 1 patient group

Chronic Kidney Disease Participants

Description:

Participants for whom the treating physician has decided to initiate treatment with MIRCERA for medical reasons prior to study start, will be observed for 9 months.

Treatment:

Drug: Methoxy Polyethylene Glycol-Epoetin Beta