CompletedNot Applicable

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)

France551 participantsStarted 2012-11-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse

Timeframe: Baseline, Month 9

Trial details

NCT IDNCT01756612

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-03-25

View on ClinicalTrials.gov More Renal Anemia of Chronic Kidney Disease trials