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NCT02000687 Clinical Trial

Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02000687
Other study ID # 20080127
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2008
Est. completion date July 2027

Study information
Verified date January 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Diabetes Research Institute Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Rodolfo Alejandro

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary determine the rate of allosensitization in patients after failed islet transplantation 10 years
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