A multi-centre trial of a new immunosuppression regime for pancreatic islet transplant recipients
A phase II, single arm multi-centre trial of thymoglobulin, belatacept and sirolimus for the prevention of hypoglycaemia in pancreatic islet transplant recipientspancreatic islet transplant recipients.
The University of Sydney
15 participants
May 15, 2019
Interventional
Conditions
Summary
A phase II multicentre single arm study of patients with type I diabetes who receive a pancreatic islet transplant for hypoglycaemia unawareness. Patients will receive Thymoglobulin induction with belatacept and sirolimus without corticosteroids. Outcomes will be compared to historical controls receiving our standard immunosuppressive protocol of, ATG induction, tacrolimus and mycophenolate mofetil. In addition patient outcomes will be compared to data with islet registry outcome data from the Collaborative Islet Transplant Registry (CITR).
Eligibility
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Interventions
Patients will be given: Thymoglobulin 6mg/kg in two divided doses (i.e. 3mg/kg per dose), dose 1 on day 1(day of transplant) and dose 2 on day 3 post-transplant will be administered by intravenous infusion. Belatacept will be administered IV at a dose of 10mg/kg on day 1 (day of transplant), day 5, weeks 2, 4, 8, 12 post-transplant followed by 5mg/kg every 4 weeks thereafter until 24 months. At the time of transplant patients will receive oral Sirolimus 5 mg daily for 3 days then 3mg daily targeting a level of 3 to 7 ng/ml for 24 months. If patients are unable to tolerate sirolimus or everolimus they will receive oral mycophenolate mofetil at a dose of 1 gram bi-daily to maintain adequate immunosuppression for 24 months. With the 2nd islet transplant patients receive Thymoglobulin 6 mg/kg in two divided doses. At the time of the 3rd islet transplant will receive basiliximab 20mg IV at the time of transplant. Fidelity will be assessed at the scheduled belatacept infusion study visits and participants will be asked about their compliance.
Locations(3)
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ACTRN12619000268145