NCT01309022

Brief Summary

The purpose of this protocol is to provide continued acess to immunosuppressive medications to subjects from the completed/closed trial ITN005CT (NIS01,NCT00014911). THIS PROTOCOL DOES NOT PROVIDE MEDICINES TO DIABETES PATIENTS WHO DID NOT PARTICIPATE IN ITN005CT.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

First QC Date

March 2, 2011

Last Update Submit

February 5, 2016

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1T1DT1DMIslets of Langerhans TransplantationPancreatic Islets TransplantationIslet TransplantTacrolimusSirolimusMycophenolate mofetilMycophenolic acid

Interventions

SirolimusDRUG

Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.

Also known as: Rapamune®
TacrolimusDRUG

Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.

Also known as: Prograf®
Mycophenolate mofetilDRUG

Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.

Also known as: MMF, CellCept
Mycophenolic acidDRUG

Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.

Also known as: Myfortic®

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in clinical trial ITN005CT (reference: ClinicalTrials.gov record NCT00014911) at Harvard University (Massachusetts General Hospital), Washington University, or University of Miami.
  • Immunosuppressive regimen consisting of a single agent or some combination from among the following: tacrolimus, sirolimus, mycophenolate mofetil, and mycophenolic acid.
  • Willingness of participants to use an approved method of contraception before, during, and 12 weeks after study participation.
  • Peak C-peptide \>0.1 pmol/mL during a mixed meal tolerance test (MMTT) within 12 months of the screening visit.

You may not qualify if:

  • Inability to understand and sign the informed consent document for this study.
  • Any medical condition which in the opinion of the investigator should preclude participation.
  • Serum creatinine \> 1.6 mg/dL
  • Insulin requirement \> 1.0 IU/kg/day
  • Hemoglobin A1C (HbA1C) result \> 12%
  • Hypoglycemia unawareness defined as the absence of adequate autonomic symptoms at plasma glucose levels of \< 54 mg/dL requiring treatment with glucagon, outside assistance, or treatment in an emergency room or hospital within a 12-month period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • 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: 17005949BACKGROUND

  • Brennan DC, Kopetskie HA, Sayre PH, Alejandro R, Cagliero E, Shapiro AM, Goldstein JS, DesMarais MR, Booher S, Bianchine PJ. Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States. Am J Transplant. 2016 Feb;16(2):509-17. doi: 10.1111/ajt.13458. Epub 2015 Oct 3.

    PMID: 26433206RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SirolimusTacrolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Daniel C. Brennan, MD

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
expanded access
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

US(3)