Extended Follow-Up After Islet Transplantation in T1D

NCT01369082 | Completed DMC

• 1 other identifier: DAIT CIT-08
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 8

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.

Conditions

Type 1 Diabetes (T1D); Islet Transplantation

Keywords

islet allograft function; c-peptide production; maintenance immunosuppressive medications

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Serum creatinine and calculated eGFR at each annual study visit

  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

  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

  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

  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

  Month 36,48,60,72,84,96,108,120,132 and 144 status post last islet transplant

Study Arms (1)

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

Interventions

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.

Also known as: tacrolimus, Prograf®, FK506, sirolimus, rapamycin, Rapamune®, cyclosporine, Neoral®, mycophenolate mofetil (MMF), CellCept®, mycophenolic sodium, Myfortic®

CIT Islet Transplantation Recipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Clinical Islet Transplantation Consortium: collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02493, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 23630300 BACKGROUND

• 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.

  PMID: 17005949 BACKGROUND

Related Links

• National Institute of Allergy and Infectious Diseases
• Division of Allergy, Immunology, and Transplantation (DAIT)
• Clinical Islet Transplantation Consortium

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Tacrolimus; Sirolimus; Cyclosporine; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 8, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

US (8)