Extended Follow-Up After Islet Transplantation in T1D

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Clinical Islet Transplantation Consortium; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Subjects who have received an islet transplant during participation in the following Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)

• A functioning pancreatic islet graft (e.g., absence of graft failure as defined in parent study) requiring immunosuppression

• Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation

• Ability to provide written informed consent

• Resident of the United States of America

• Documentation of the existence or lack of health insurance coverage and whether immunosuppressants are covered.

Exclusion Criteria:

• For female subjects-Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation

• For male subjects-Intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.

• Received an islet transplant in a non-CIT research study

• Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.