Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

January 29, 2024 updated by: Rodolfo Alejandro
This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Diabetes Research Institute
        • Contact:
        • Sub-Investigator:
          • David A Baidal, MD
        • Contact:
        • Principal Investigator:
          • Rodolfo Alejandro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ages 18-75 years old that received at least one IT. Participants will be obtained from the pool of islet transplant recipients transplanted at the Diabetes Research Institute at the University of Miami, Miller School of Medicine.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine the rate of allosensitization in patients after failed islet transplantation
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rodolfo Alejandro

Investigators

  • Principal Investigator: Rodolfo Alejandro, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimated)

December 4, 2013

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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