CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Alpha 1-Antitrypsin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02464878
NCT02464878Phase 2Completed
CompareCT.gov

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

Massachusetts General Hospital·interventional·Posted Jun 8, 2015·Updated Dec 22, 2023

In Brief

A Phase 2 clinical trial evaluating Alpha 1-Antitrypsin, Islet Transplantation, and 3 other interventions for Kidney Transplant and Type 1 Diabetes. Completed, enrolled 2 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant, Type 1 Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Iowa

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 8, 2015
Enrollment StartJan 1, 2017
Primary CompletionNov 1, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 11.1 years ago

Interventions

Alpha 1-Antitrypsindrug

Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.

Islet Transplantationprocedure

Thymoglobulindrug

Patients will receive a total of 5 doses between Day -2 and Day +2

Basiliximabdrug

Basiliximab will be used for subsequent transplants.

Etanerceptdrug

Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.