RecruitingPhase 2ACTRN12619000268145

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.


Sponsor

The University of Sydney

Enrollment

15 participants

Start Date

May 15, 2019

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Type 1 diabetes can sometimes cause a dangerous condition called hypoglycaemia unawareness — where the body loses the ability to sense and respond to dangerously low blood sugar. For people with severe, recurring episodes that cannot be controlled through standard treatments, a pancreatic islet transplant (transplanting insulin-producing cells from a donor pancreas) can restore this awareness and reduce the need for insulin injections. After a transplant, patients must take immunosuppressive medications for life to prevent the body from rejecting the new cells. This Phase 2 trial is testing a new combination of immunosuppressive drugs — belatacept and sirolimus — as an alternative to the standard regimen. The goal is to maintain transplant success while potentially causing fewer side effects, particularly for the kidneys. You may be eligible if you have had Type 1 diabetes for more than five years, have severe recurrent low blood sugar episodes that don't respond to standard therapy, and meet specific health criteria including good kidney function and a weight under 85 kg. People with prior organ transplants, significant heart, liver or lung disease, HIV, hepatitis B or C, or a history of cancer (other than certain skin cancers) would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 in

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)

Westmead Hospital - Westmead

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12619000268145


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