Type 1 Diabetes MellitusPhase 1/2NCT00784966
Islet After Kidney Transplant for Type 1 Diabetes
A Phase 1/2 study testing etanercept in people with Type 1 Diabetes Mellitus, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2017
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.
Who cannot join
- Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
- Active infections (clinically or by laboratory testing)
- History of current malignancy or suspicion of malignancy until properly investigated and excluded
- Liver or biliary abnormalities
- Unstable cardiovascular disease
- Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
About this study
Official title: Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- etanercept
- Keywords
- Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation
- 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.
etanerceptDrug
Also called Enbrel
Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.
etanerceptDrug
Also called Enbrel
Etanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Two weeks etanercept post islet transplant Receives: Drug: etanercept |
| 2 | Active comparator | Two months etanercept treatment post islet transplant Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
Measured: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.
Secondary outcomes (1)
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.
Measured: Outcome measures will be assessed at protocol prescribed intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startAug 2011
- Primary completionSep 2015 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: University decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Adrian H Cotterell, M.D., Principal investigator, Virginia Commonwealth University Health SystemJohn N Clore, M.D., Principal investigator, Virginia Commonwealth University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784966
- Sponsor's protocol ID
- VCU IRB 4196
- Status last verified
- Sep 2014
- First submitted
- 4 Nov 2008
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00784966
- Acronym / sponsor ID
- VCU IRB 4196
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Islet transplantation, Type 1 Diabetes Mellitus, Kidney Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: University decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Aug 2011
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 5 Nov 2008 (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 study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: etanerceptTwo weeks etanercept post islet transplant |
| 2 | Active comparator | Drug: etanerceptTwo months etanercept treatment post islet transplant |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.
Key exclusion criteria (6 listed)
- Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
- Active infections (clinically or by laboratory testing)
- History of current malignancy or suspicion of malignancy until properly investigated and excluded
- Liver or biliary abnormalities
- Unstable cardiovascular disease
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 |
|---|---|---|
| etanerceptAlso: EnbrelTreatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks. | Drug | 1 |
| etanerceptAlso: EnbrelEtanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months. | Drug | 2 |
Primary outcome
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
Time frame: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.
1 secondary outcome
Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.
Time frame: Outcome measures will be assessed at protocol prescribed intervals.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Adrian H Cotterell, M.D. principal investigator
Virginia Commonwealth University Health System
John N Clore, M.D. principal investigator
Virginia Commonwealth University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing etanercept in people with Type 1 Diabetes Mellitus, run by Virginia Commonwealth University at 1 site 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 1 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: withdrawn, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy. (time frame: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2014.