NCT01999361

Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Rodolfo Alejandro · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Myfortic	treatment with myfortic

Timeline

• Start date: 2009-01-01
• Primary completion: 2027-01-01
• Completion: 2028-12-01
• First posted: 2013-12-03
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States