N/A
Completed N=1,288
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
Source: ClinicalTrials.gov NCT01356589 ↗Enrolled (actual)
1,288
Serious AEs
—
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With at Least One Hemoglobin Cycling — 31.84 percentage of participants
Summary
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Hemoglobin Cycling |
31.84 | — |
| SECONDARY Number of Full Hemoglobin Cycles Per Participant |
0.38 | — |
| SECONDARY Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling |
29.83 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic kidney disease in predialysis (stage 3 and 4) and dialysis
- Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent
Exclusion Criteria
- Participation in an interventional clinical trial within the retrospective observation period
- Contraindications to Mircera administration as per label or judged by the investigator
Data sourced from ClinicalTrials.gov (NCT01356589). 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.