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

NCT02464878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-12-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Iowa

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jim Markmann, M.D. Ph.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-11-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464878 on ClinicalTrials.gov