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Summary

for people ages 18–65 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

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)

Keywords

Type 1 Diabetes (T1D) Islet Transplantation islet allograft function c-peptide production maintenance immunosuppressive medications Diabetes Mellitus, Type 1 Tacrolimus Cyclosporins Cyclosporine Sirolimus Immunosuppressive Agents Mycophenolic Acid

Eligibility

You can join if…

Open to people ages 18–65

  • 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 CAN'T join 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.

Locations

  • University of California, San Francisco
    San Francisco, California, 94143, United States
  • University of Minnesota
    Minneapolis, Minnesota, 55455, United States
  • University of Illinois
    Chicago, Illinois, 60612, United States
  • Northwestern University
    Chicago, Illinois, 60611, United States
  • Emory University
    Atlanta, Georgia, 30322, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania, 19104, United States
  • University of Miami
    Miami, Florida, 33136, United States
  • Massachusetts General Hospital
    Boston, Massachusetts, 02493, United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Diabetes and Digestive and Kidney Diseases
Clinical Islet Transplantation Consortium
ID
NCT01369082
Phase
Phase 3
Lead Scientist
Andrew Posselt
Study Type
Observational
Last Updated
October 2016