Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extended Follow-Up After Islet Transplantation in T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01369082
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : November 9, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Clinical Islet Transplantation Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date June 3, 2011
First Posted Date June 8, 2011
Last Update Posted Date November 9, 2017
Study Start Date May 2011
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2015)
Duration of sustained islet allograft function [ Time Frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant ]
A C-peptide >/= 0.3 ng/mL at 0, 60, or 90 minutes after a Mixed-Meal Tolerance Test (MMTT) will be considered evidence of insulin production by transplanted islets
Original Primary Outcome Measures
 (submitted: June 7, 2011)
  • Duration of sustained islet allograft function [ Time Frame: 36 months ]
  • Duration of sustained islet allograft function [ Time Frame: 48 months ]
Change History
Current Secondary Outcome Measures
 (submitted: July 22, 2015)
  • Serum creatinine and calculated eGFR at each annual study visit [ Time Frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant ]
    Measured as part of each annual follow-up evaluation
  • Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit [ Time Frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant ]
    Insulin usage will be estimated from the one-week self report values
  • Insulin requirements during a one-week period preceding each annual study visit [ Time Frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant ]
    Insulin usage will be estimated from the one-week self report values
  • Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit [ Time Frame: 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months ]
    Numbers of severe hypoglycemic events will be estimated from the self report values obtained at each follow-up visit. Defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, IV glucose, or glucagon administration.
  • HbA1c levels at each annual study visit [ Time Frame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant ]
    Glycosylated hemoglobin test determination during each follow-up visit
  • Incidence of all-cause mortality [ Time Frame: By month 144 status post last islet transplant ]
  • Donor-specific alloantibodies [ Time Frame: By month 144 status post last islet transplant ]
    Subjects with confirmed graft failure will continue with annual study visits; however, metabolic assessments should not be completed. Subjects who were enrolled in islet-alone parent studies and who experience graft failure and subsequently stop immunosuppression will have alloantibody assessed 3 months after their last dose of immunosuppression.
Original Secondary Outcome Measures
 (submitted: June 7, 2011)
  • Serum creatinine and calculated eGFR at each annual study visit [ Time Frame: 36 months and 48 months ]
  • Incidence of serious adverse events during the 12-month period preceding each annual study visit [ Time Frame: 36 months and 48 months ]
  • Insulin requirements during a one-week period preceding each annual study visit [ Time Frame: 36 months and 48 months ]
  • Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit [ Time Frame: 36 months and 48 months ]
  • HbA1c levels at each annual study visit [ Time Frame: 36 months and 48 months ]
  • Donor-specific alloantibodies at each annual study visit [ Time Frame: 36 months and 48 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Extended Follow-Up After Islet Transplantation in T1D
Official Title Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)
Brief 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.
Detailed Description

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)

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Participants are given the option to provide consent for:

  1. the collection and storage of blood samples for future research studies
  2. the collection and storage of blood samples for future genetic (i.e., DNA) testing.
Sampling Method Probability Sample
Study Population

Cohort from Clinical Islet Transplantation (CIT) parent studies (refer to inclusion criteria) who continue:

  • to have islet graft function and
  • are on prescribed immunosuppression medications to prevent rejection of their transplant.
Condition
  • Type 1 Diabetes (T1D)
  • Islet Transplantation
Intervention Drug: Maintenance Immunosuppressive Treatment
All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08.
Other Names:
  • tacrolimus
  • Prograf®
  • FK506
  • sirolimus
  • rapamycin
  • Rapamune®
  • cyclosporine
  • Neoral®
  • mycophenolate mofetil (MMF)
  • CellCept®
  • mycophenolic sodium
  • Myfortic®
Study Groups/Cohorts CIT Islet Transplantation Recipients

Subjects who received an islet-cell transplant for Type 1 Diabetes (T1D) while enrolled in one of the Clinical Islet Transplantation (CIT) parent studies and continue to have islet graft function. All subjects will continue immunosuppressive medications under CIT08. Detailed follow-up evaluations including but not limited to islet function will occur on an annual basis.

The immunosuppressive medications (e.g., tacrolimus, sirolimus, cyclosporine, mycophenolate mofetil [MMF], mycophenolic sodium) in this study are obtained by prescription unless provided by the study through the drug distributor. Generic brands are allowed, when available. Antibacterial, antifungal, and antiviral prophylaxis, insulin therapy, and other standard therapies will be provided per site-specific practices.

Intervention: Drug: Maintenance Immunosuppressive Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2015)
75
Original Estimated Enrollment
 (submitted: June 7, 2011)
40
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01369082
Other Study ID Numbers DAIT CIT-08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Clinical Islet Transplantation Consortium
Investigators
Principal Investigator: Bernhard Hering, MD University of Minnesota
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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date November 2017