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Completed

NCT Number: NCT01369082

Extended Follow-Up After Islet Transplantation in T1D

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Islet Transplantation Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. Incidence of all-cause mortality

    Time frame: By month 144 status post last islet transplant

  7. 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.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Islet Transplantation Consortium
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2011
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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