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Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

Primary Purpose

Diabetes Mellitus, Type 1

Status

No longer available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Sirolimus

Tacrolimus

Mycophenolate mofetil

Mycophenolic acid

About this trial

This is an expanded access trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, T1D, T1DM, Islets of Langerhans Transplantation, Pancreatic Islets Transplantation, Islet Transplant, Tacrolimus, Sirolimus, Mycophenolate mofetil, Mycophenolic acid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

University of Miami
Massachusetts General Hospital
Washington University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01309022

First Posted

March 2, 2011

Last Updated

February 5, 2016

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

1. Study Identification

Unique Protocol Identification Number

NCT01309022

Brief Title

Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

Official Title

Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)

Study Type

Expanded Access

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Immune Tolerance Network (ITN)

4. Oversight

5. Study Description

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.

Detailed Description

Study acronym: EXIIST - Extended Immunosuppression in Islet Transplantation Islet transplantation is an experimental therapy in people with difficult to control Type 1 diabetes (T1D). Insulin producing cells (islets) are isolated from a pancreas. After the cells are prepared, the islets are put into the subject's liver. These transplanted islets may produce insulin that the subject's islets can no longer make. In order to help keep up the function of the transplanted islets, immunosuppressive medications must be given indefinitely or for as long as the study doctor determines is necessary. The medications serve to modify the immune system that normally tries to destroy (reject) new islets. Participants in this study have received up to three islet cell infusions as a previous participant in the ITN005CT (NIS01) protocol. They also received a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil (MMF, Cellcept®), and/or mycophenolic acid (MPA, Myfortic®).) This protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make C-peptide. Routine study follow-up visits will occur on an annual and -as warranted basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, T1D, T1DM, Islets of Langerhans Transplantation, Pancreatic Islets Transplantation, Islet Transplant, Tacrolimus, Sirolimus, Mycophenolate mofetil, Mycophenolic acid

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Sirolimus

Other Intervention Name(s)

Rapamune®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Other Intervention Name(s)

Prograf®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mycophenolate mofetil

Other Intervention Name(s)

MMF, CellCept

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mycophenolic acid

Other Intervention Name(s)

Myfortic®

Intervention Description

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

10. Eligibility

Sex

All

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel C. Brennan, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Washington University

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17005949

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.

Results Reference

background

PubMed Identifier

26433206

Citation

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.

Results Reference

result

Links:

URL

http://www.immunetolerance.org

Description

Immune Tolerance Network (ITN) Web Site

Learn more about this trial

Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)

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