Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Male and female patients age 18-70 years of age.
• Ability to provide written informed consent.
• Mentally stable and able to comply with the procedures of the study protocol.
• Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
• History of at least one islet transplant.
• Stimulated C-peptide \<0.3 ng/ml.
Locations
United States
Florida
Diabetes Research Institute
RECRUITING
Miami
Time Frame
Start Date: 2009-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 18
Treatments
Experimental: Myfortic treatment
Treatment with Myfortic
Related Therapeutic Areas
Sponsors
Leads: Rodolfo Alejandro