Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:12/13/2018
Start Date:December 2008
End Date:July 2023

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This is a single-center, prospective, open label study in islet transplant recipients
following islet graft loss.

After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e.
sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored
for 10 years thereafter, for the appearance of allosensitization using panel reactive
antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective
is to determine the rate of allosensitization in patients 3 years after failed islet
transplantation (i.e. stimulated c-peptide <0.3mg/mL) and monitor the persistence of elevated
PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be
monitored after all immunosuppression is discontinued.

Inclusion Criteria:

1. History of at least one islet alone transplant (ie islet transplant in the absence of
any other organ transplant).

Exclusion Criteria:

1. Inability to provide written informed consent.

2. Mentally unstable and/or unable to comply with the procedures of the study protocol.

3. History of any solid organ transplant.
We found this trial at
1
site
Miami, Florida 33136
Principal Investigator: Rodolfo Alejandro, MD
Phone: 305-243-5321
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mi
from
Miami, FL
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