NCT01369082

Extended Follow-Up After Islet Transplantation in T1D

Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.

Detailed description

After islet-cell transplantation in the CIT studies\*, each subject receives maintenance immunosuppressive medications. The purpose of this protocol is to collect additional follow-up for safety and efficacy from CIT subjects with graft function after their completion in their CIT parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their CIT parent study. \*CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)

Conditions

• Type 1 Diabetes (T1D)
• Islet Transplantation

Interventions

Type	Name	Description
DRUG	Maintenance Immunosuppressive Treatment	All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08.

Timeline

• Start date: 2011-05-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2011-06-08
• Last updated: 2017-11-09

Locations

8 sites across 1 country: United States