NCT02464878

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Patients meeting the study entry criteria will receive 1-3 infusion(s) of in vitro cultured islets. Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

Conditions

• Kidney Transplant
• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Alpha 1-Antitrypsin	Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.
PROCEDURE	Islet Transplantation
DRUG	Thymoglobulin	Patients will receive a total of 5 doses between Day -2 and Day +2
DRUG	Basiliximab	Basiliximab will be used for subsequent transplants.
DRUG	Etanercept	Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2015-06-08
• Last updated: 2023-12-22
• Results posted: 2023-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study