Caspase Inhibition in Islet Transplantation

Diabetes Clinical Trial

Official title: Improving Engraftment, Islet Survival and Metabolic Reserve in Clinical Islet Transplantation Using Caspase Inhibitor - IDN-6556

Status Completed

Clinical Trial Summary

This is an Investigator Initiated, Phase I/II study, where Type 1 diabetic participants will receive a 14 day oral treatment of the investigational caspase inhibitor drug IDN-6556 following their first islet transplant. Two pilot studies are proposed to establish the optimal safety and efficacy dose of IDN-6556 (25 mg twice daily (Pilot 1) or a loading dose of 100 mg two hours prior to transplantation, then two 50 mg doses following transplant (Day 0) (Pilot 2). This will be followed by 50 mg three times daily). Participants of both pilot studies will receive islet cell transplants under the University of Alberta's standard-of-care therapy.

Secondary objectives include:

1. To determine the proportion of subjects treated with IDN-6556 who achieve and maintain insulin independence after the first or subsequent islet transplant.

2. To obtain preliminary data on the efficacy of IDN-6556 to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetes

• NCT number: NCT01653899
• Study type: Interventional
• Source: University of Alberta
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2012
• Completion date: June 2016