Diabetes Mellitus, Type 1NCT01309022
Immunosuppressive Medications for Participants in ITN005CT (NCT00014911)
A study testing Sirolimus, Tacrolimus and Mycophenolate mofetil in people with Diabetes Mellitus, Type 1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Sirolimus, Tacrolimus and Mycophenolate mofetil
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Miami
Miami, Florida, 33136
Washington University
St Louis, Missouri, 63110
About this study
Official title: Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Sirolimus, Tacrolimus, Mycophenolate mofetil, Mycophenolic acid
- Keywords
- Diabetes Mellitus, Type 1, T1D, T1DM, Islets of Langerhans Transplantation, Pancreatic Islets Transplantation, Islet Transplant, Tacrolimus, Sirolimus, Mycophenolate mofetil, Mycophenolic acid
- 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.
SirolimusDrug
Also called Rapamune®
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
TacrolimusDrug
Also called Prograf®
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
Also called MMF, CellCept
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
Mycophenolic acidDrug
Also called Myfortic®
Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Daniel C. Brennan, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309022
- Sponsor's protocol ID
- DAIT ITN040CT
- Other IDs
- EXIIST
- Status last verified
- Feb 2016
- First submitted
- 2 Mar 2011
- Last updated
- 9 Feb 2016
- Results posted
- No
Publications
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 17005949Brennan 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.
PubMed 26433206
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)
- ClinicalTrials.gov ID
- NCT01309022
- Acronym / sponsor ID
- DAIT ITN040CT
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, T1D, T1DM, Islets of Langerhans Transplantation, Pancreatic Islets Transplantation, Islet Transplant, Tacrolimus, Sirolimus
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: Rapamune®Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911. | Drug | – |
| TacrolimusAlso: Prograf®Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911. | Drug | – |
| Mycophenolate mofetilAlso: MMF, CellCeptObtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911. | Drug | – |
| Mycophenolic acidAlso: Myfortic®Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Background: PubMed 17005949Shapiro 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 publication: PubMed 26433206Brennan 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.
- Immune Tolerance Network (ITN) Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C. Brennan, MD study chair
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus, Tacrolimus and Mycophenolate mofetil in people with Diabetes Mellitus, Type 1, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01309022, 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 Feb 2016.