Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

N/ARecruitingNCT02000687

Rodolfo Alejandro60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes Mellitus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Diabetes Research Institute

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

determine the rate of allosensitization in patients after failed islet transplantation

Time frame: 10 years

Data from ClinicalTrials.gov

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