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Type 1 Diabetes (T1D)NCT01369082

Extended Follow-Up After Islet Transplantation in T1D

An observational study of Type 1 Diabetes (T1D) and Islet Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes (T1D), Islet Transplantation
What is being tested?
Maintenance Immunosuppressive Treatment
How many people
75 participants
Where
8 sitesUnited States
Study dates
May 2011to Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital

    Boston, Massachusetts, 02493

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Miami

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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

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.

Read the 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)

Being tested
Maintenance Immunosuppressive Treatment
Keywords
islet allograft function, c-peptide production, maintenance immunosuppressive medications
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maintenance Immunosuppressive TreatmentDrug

    Also called tacrolimus, Prograf®, FK506, sirolimus

    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.

Study groups in NCT01369082
Study groupRoleWhat they receive
CIT Islet Transplantation RecipientsSubjects 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.
Receives: Drug: Maintenance Immunosuppressive Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

  1. Serum creatinine and calculated eGFR at each annual study visit

    Measured as part of each annual follow-up evaluation

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

  2. Incidence of serious adverse events (SAEs) during the 12-month period preceding each annual study visit

    Insulin usage will be estimated from the one-week self report values

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

  3. Insulin requirements during a one-week period preceding each annual study visit

    Insulin usage will be estimated from the one-week self report values

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

  4. 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.

    Measured: 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months, 132 months and 144 months

  5. HbA1c levels at each annual study visit

    Glycosylated hemoglobin test determination during each follow-up visit

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

  6. Incidence of all-cause mortality

    Measured: By month 144 status post last islet transplant

  7. 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.

    Measured: By month 144 status post last islet transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369082
Sponsor's protocol ID
DAIT CIT-08
Status last verified
Nov 2017
First submitted
3 Jun 2011
Last updated
9 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23630300

  • 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.

    PubMed 17005949

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes (T1D) and Islet Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.

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