Phase 4
N=6
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Nephrotoxicity
Bottom Line
View on ClinicalTrials.gov: NCT02103855 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Aug 2017
Primary outcome: Primary: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) — 2.25 ml/min/1.73m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Belatacept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) |
2.25 | — |
| PRIMARY Serum Creatinine at Year 1 |
1.8 | — |
| SECONDARY Number of Participants With Pancreas Transplant Rejection |
2 | — |
| SECONDARY Change From Baseline Serum Hemoglobin A1c |
5.9 | — |
| SECONDARY Pancreas Transplant Function as Measured by Fasting Serum Glucose Level. |
96.9 | — |
Summary
Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.
Eligibility Criteria
Inclusion Criteria
- Pancreas transplant alone recipients
- EBV IgG positive
- Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
- Maintained on a regimen of tacrolimus, sirolimus, mycophenolate
Exclusion Criteria
- EBV IgG negative
- Not maintained on an immunosuppression regimen that contains tacrolimus
- Unable or unwilling to give informed consent
- Active infection
- History of malignancy post transplant
- Glomerular filtration rate < 15 mL/min
Data sourced from ClinicalTrials.gov (NCT02103855). 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.