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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Clinical Islet Transplantation Consortium | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintenance Immunosuppressive Treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sustained islet allograft function | 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 | Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine and calculated eGFR at each annual study visit | Measured as part of each annual follow-up evaluation | Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant |
| Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort from Clinical Islet Transplantation (CIT) parent studies (refer to inclusion criteria) who continue:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23630300 | Background | Rickels MR, Liu C, Shlansky-Goldberg RD, Soleimanpour SA, Vivek K, Kamoun M, Min Z, Markmann E, Palangian M, Dalton-Bakes C, Fuller C, Chiou AJ, Barker CF, Luning Prak ET, Naji A. Improvement in beta-cell secretory capacity after human islet transplantation according to the CIT07 protocol. Diabetes. 2013 Aug;62(8):2890-7. doi: 10.2337/db12-1802. Epub 2013 Apr 29. | |
| 17005949 |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D020123 | Sirolimus |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
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Participants are given the option to provide consent for:
|
Insulin usage will be estimated from the one-week self report values |
| Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant |
| Insulin requirements during a one-week period preceding each annual study visit | Insulin usage will be estimated from the one-week self report values | Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant |
| Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit | 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. | 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months |
| HbA1c levels at each annual study visit | Glycosylated hemoglobin test determination during each follow-up visit | Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant |
| Incidence of all-cause mortality | By month 144 status post last islet transplant |
| Donor-specific alloantibodies | 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. | By month 144 status post last islet transplant |
| Miami |
| Florida |
| 33136 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02493 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Shapiro AM, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems JA, Bretzel RG, Bertuzzi F, Froud T, Kandaswamy R, Sutherland DE, Eisenbarth G, Segal M, Preiksaitis J, Korbutt GS, Barton FB, Viviano L, Seyfert-Margolis V, Bluestone J, Lakey JR. International trial of the Edmonton protocol for islet transplantation. N Engl J Med. 2006 Sep 28;355(13):1318-30. doi: 10.1056/NEJMoa061267. |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| Clinical Islet Transplantation Consortium | View source |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010456 |
| Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |