Extended Follow-Up After Islet Transplantation in T1D
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|ClinicalTrials.gov Identifier: NCT01369082|
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : November 9, 2017
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|Condition or disease||Intervention/treatment|
|Type 1 Diabetes (T1D) Islet Transplantation||Drug: Maintenance Immunosuppressive Treatment|
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|
|Actual Enrollment :||75 participants|
|Official Title:||Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
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.
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.
- 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
- 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.
Biospecimen Retention: Samples With DNA
Participants are given the option to provide consent for:
- the collection and storage of blood samples for future research studies
- the collection and storage of blood samples for future genetic (i.e., DNA) testing.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369082
|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|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|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|
|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|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||June 8, 2011 Key Record Dates|
|Last Update Posted:||November 9, 2017|
|Last Verified:||November 2017|
islet allograft function
maintenance immunosuppressive medications
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action