Overview

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)

Status:
Completed
Trial end date:
2015-03-25
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Epoetin Alfa
Criteria
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