N/A
Completed N=290
An Observational Study of Methoxy Polyethylene Glycol-epoetin Beta in Participants With a Kidney Transplant
Anemia, Kidney Transplantation
Source: ClinicalTrials.gov NCT02538107 ↗
Enrolled (actual)
290
Serious AEs
11.5%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) — 20.7 percentage of participants
Summary
This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) |
20.7 | — |
| PRIMARY Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) |
40.4 | — |
| PRIMARY Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) |
21.2 | — |
| PRIMARY Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) |
12.2 | — |
| PRIMARY Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) |
52.6 | — |
| PRIMARY Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) |
41.2 | — |
| PRIMARY Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment |
9.31 | — |
| SECONDARY Hemoglobin Level Based on the Type of Kidney Transplantation Performed |
11.08; 11.26; 11.37; 11.41; 11.34; 11.71 | — |
| SECONDARY Hemoglobin Level Based on the Presence of Inflammatory Diseases |
11.30; 11.20; 11.33; 11.44; 11.75; 11.61 | — |
| SECONDARY Hemoglobin Level Based on the Etiology of Chronic Kidney Disease |
11.27; 11.44; 11.42; 11.48; 11.79; 11.75 | — |
| SECONDARY Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study |
11.23; 11.40; 11.65; 11.51; 11.75; 11.57 | — |
| SECONDARY Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) |
11.15; 11.44; 11.17; 11.42; 11.60; 11.65 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor.
- The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis.
Exclusion Criteria
- Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (>/=) 2 g/dL between two sequential values.
- Administration of other ESA therapies during the observation period.
Data sourced from ClinicalTrials.gov (NCT02538107). 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.