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Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Status

Enrolling

Conditions

Type 1 Diabetes Mellitus

Study type

Observational

Funder types

Other

Identifiers

NCT02000687
20080127

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial contacts and locations

1

There are currently no registered sites for this trial.

Timeline

Last updated: Jan 31, 2024

Start date

Dec 01, 2008 • 16 years ago

Today

Jan 20, 2025

End date

Dec 01, 2026 • in 1 year and 10 months

Sponsor of this trial

Lead Sponsor

Data sourced from clinicaltrials.gov