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)
Sponsored by Hoffmann-La Roche
About this trial
Last updated 6 years ago
Study ID
ML28145
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 10 years ago
What is this trial 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.
What are the participation requirements?
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