Extended Follow-Up After Islet Transplantation in Type 1 Diabetes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01369082
First received: June 3, 2011
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Islet Transplantation
Drug: Tacrolimus, sirolimus cyclosporine, mycophenolate mofetil, mycophenolic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Duration of sustained islet allograft function [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Duration of sustained islet allograft function [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum creatinine and calculated eGFR at each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: Yes ]
  • Incidence of serious adverse events during the 12-month period preceding each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: Yes ]
  • Insulin requirements during a one-week period preceding each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: No ]
  • Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: Yes ]
  • HbA1c levels at each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: No ]
  • Donor-specific alloantibodies at each annual study visit [ Time Frame: 36 months and 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maintenance immunosuppression Drug: Tacrolimus, sirolimus cyclosporine, mycophenolate mofetil, mycophenolic acid
Maintenance immunosuppression therapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participation in any of the following CIT parent studies: CIT02, CIT03, CIT04, CIT05, CIT-06 and CIT07.
  2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study)requiring immunosuppression.
  3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
  4. Ability to provide written informed consent.
  5. Resident of the United States of America.
  6. Documentation of the existence or lack of health insurance coverage and whether immunosuppressants are covered.

Exclusion Criteria:

  1. 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.
  2. Received an islet transplant in a non-CIT research study.
  3. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369082

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02493
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 57392
Sponsors and Collaborators
Investigators
Principal Investigator: Bernhard Hering, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Ali Naji, PhD University of Pennsylvania
Principal Investigator: Camillo Ricordi, MD University of Miami
Principal Investigator: Andrew Posselt, MD, PhD University of California, San Francisco
Principal Investigator: Nicole Turgeon, MD Emory University
Principal Investigator: Xunrong Luo, MD, PhD Northwestern University
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01369082     History of Changes
Other Study ID Numbers: DAIT CIT-08
Study First Received: June 3, 2011
Last Updated: May 30, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Type 1 diabetes
Clinical Islet Cell Consortium
Islet transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014