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

June 3, 2011
May 30, 2014
May 2011
July 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01369082 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Extended Follow-Up After Islet Transplantation in Type 1 Diabetes
Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 1 Diabetes
  • Islet Transplantation
Drug: Tacrolimus, sirolimus cyclosporine, mycophenolate mofetil, mycophenolic acid
Maintenance immunosuppression therapy
Experimental: Maintenance immunosuppression
Intervention: Drug: Tacrolimus, sirolimus cyclosporine, mycophenolate mofetil, mycophenolic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
40
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369082
DAIT CIT-08
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
National Institute of Allergy and Infectious Diseases (NIAID)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP