Extended Follow-Up After Islet Transplantation in T1D

Completed

Conditions studied: Type 1 Diabetes (T1D), Islet Transplantation

In brief

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.

Key facts

Study ID

NCT01369082

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Starts

2011-05-01

Expected to finish

2017-07-01

Last updated by the study team

2017-11-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Illinois — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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