NCT02000687

Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Rodolfo Alejandro · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Timeline

• Start date: 2008-12-01
• Primary completion: 2027-12-01
• Completion: 2028-07-01
• First posted: 2013-12-04
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States