Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02000687

Enrollment

Registered

2013-12-04

Start date

2008-12-01

Completion date

2028-07-01

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
determine the rate of allosensitization in patients after failed islet transplantation	10 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRodolfo Alejandro, MD

University of Miami

Outcome results