Renal Anemia of Chronic Kidney Disease
Conditions
Brief 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.
Interventions
DRUGMethoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Baseline, Month 9 |
Secondary
| Measure | Time frame |
|---|---|
| Average Dose of Mircera in Total Population | Baseline up to 9 months |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population | Baseline up to 9 months |
| Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation | Baseline up to 9 months |
| Hemoglobin Levels According to Liu Index and Resistance Factors | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| Duration of Treatment With Mircera | Baseline up to 9 months |
| Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia | Baseline up to 9 month |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation | Baseline up to 9 months |
Countries
France
Outcome results
None listed