N/A
Completed N=197
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis
Chronic Kidney Diseases
Source: ClinicalTrials.gov NCT02238080 ↗
Enrolled (actual)
197
Serious AEs
24.4%
Results posted
Apr 2017
Primary outcomePrimary: Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose — 0.1485 correlation coefficient
Summary
This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose |
0.1485 | — |
| PRIMARY Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose |
0.05557 | — |
| SECONDARY Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 |
46.5; 29.9; 23.5 | — |
| SECONDARY Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 |
175.2; 13.6 | — |
| SECONDARY Serum CRP Level |
13.7; 16.3 | — |
| SECONDARY Serum IL-6 Level |
15.8; 16.7 | — |
| SECONDARY Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 |
0.12684 | — |
| SECONDARY Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 |
0.19473 | — |
| SECONDARY Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose |
— | — |
| SECONDARY Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose |
— | — |
| SECONDARY Serum Hemoglobin Level |
11.2; 11.2 | — |
Eligibility Criteria
Inclusion Criteria
- CKD participants undergoing dialysis
- Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
- Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)
Exclusion Criteria
- Conditions known to cause inadequate response to ESA treatment
- Anemia other than symptomatic anemia associated with CKD
Data sourced from ClinicalTrials.gov (NCT02238080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.