Clinical trial NCT01369082: Extended Follow-Up After Islet Transplantation in T1D
Official title: Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes (T1D)
Islet Transplantation
Keywords: islet allograft function
c-peptide production
maintenance immunosuppressive medications
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Clinical Islet Transplantation Consortium
First posted: 2011-06-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

Primary outcomes:
measure: Duration of sustained islet allograft function
timeFrame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
Secondary outcomes:
measure: Serum creatinine and calculated eGFR at each annual study visit
timeFrame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
measure: Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit
timeFrame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
measure: Insulin requirements during a one-week period preceding each annual study visit
timeFrame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
measure: Incidence of severe hypoglycemic events during the 12-month period preceding each annual study visit
timeFrame: 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months
measure: HbA1c levels at each annual study visit
timeFrame: Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant
measure: Incidence of all-cause mortality
timeFrame: By month 144 status post last islet transplant
measure: Donor-specific alloantibodies
timeFrame: By month 144 status post last islet transplant
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Minnesota
name: Bernhard Hering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Ali Naji, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Camillo Ricordi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Andrew Posselt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Nicole Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Xunrong Luo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.