Clinical trial NCT01999361: Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Official title: Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.

Detailed description: After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients age 18-70 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
5. History of at least one islet transplant.
6. Stimulated C-peptide \<0.3 ng/ml.

Exclusion Criteria:

1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
2. For female participants: Positive pregnancy test or presently breast-feeding.
3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
5. Known active alcohol or substance abuse.
6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \<30%.
7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient.
8. Evidence of inter-current infection.
9. Active peptic ulcer disease
10. History on non-adherence to prescribed regimens including immunosuppression.
11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.

Primary outcomes:
measure: allosensitization after complete islet graft loss
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Diabetes Research Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Rodolfo Alejandro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.