Diabetes Mellitus, Type 1Phase 2NCT00315588
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
A Phase 2 study testing Islet Transplantation in people with Diabetes Mellitus, Type 1, run by Rodolfo Alejandro at 1 site in United States.
Trial summary
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Islet Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 between 18 and 60 years of age.
- Patients with type 1 diabetes mellitus.
- Patients with a renal transplant that is more than 6 months old.
- Patients with stable renal graft function for the preceding 6 months, i.e. no episodes of rejection and changes in serum creatinine no more than 0.5 mg/dl from baseline.
- Patients who are taking tacrolimus, sirolimus +/- steroids for maintenance immunosuppression for at least 6 months and are tolerating levels satisfactory for islet transplantation without severe complications.
- Patients with a body mass index (BMI) of less than or equal to 26.
Who cannot join
- Stimulated or basal C-peptide > 0.3 ng/ml.
- Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
- Patients with proteinuria (albuminuria > 300 mg in 24 hours +/- protein) of new onset since kidney transplantation. If proteinuria or albuminuria is thought to originate from the native kidney(s) this will not be an exclusion criterion.
- Patients with corrected creatinine clearance of less than 40.
- Patients weighing more than 80 kg.
- Patients with a body mass index (BMI) of greater than 26.
Show all 29Show fewer
- Insulin requirement > 1.0 U/kg/d.
- Anemia (hemoglobin: males < 11.0 g/dl; females < 10.0 g/dl).
- Abnormal liver function tests (consistently > 1.5 x normal range).
- Unstable diabetic retinopathy.
- Evidence of acute or chronic active Epstein-Barr virus (EBV) infection (IgM ≥ IgG). Patients will be eligible if serological testing becomes consistent with previous exposure (i.e. IgG > IgM).
- Patients with history of malignancy or current malignancy other than non-melanomatous skin cancer, or finding of any lesions or symptoms during screening that are suspicious for malignancy, until properly investigated and ruled out.
- Patients with elevation of prostate-specific antigen > 4 unless malignancy has been excluded.
- Patients with unstable cardiovascular status.
- Patients with active infections until adequately treated, unless treatment is not judged as necessary by the investigators (including, but not limited to, mild skin and nail fungal infections).
- Patients with serological evidence of infection with HIV, human t cell lymphotropic virus 1 (HTLV 1), HTLV 2, or hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable).
- Patients with history and/or serological evidence of hepatitis C (those patients with hepatitis C, already transplanted in this protocol will continue in this trial).
- Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided).
- Patients with active peptic ulcer disease, gallstones, hepatic hemangioma, or portal hypertension.
- Patients who are pregnant or breastfeeding, or who intend to procreate.
- Patients who are sexually active females who are not:
- post-menopausal,
- surgically sterile, or
- using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices combined with spermicidal gel are acceptable; condoms used alone are not acceptable).
- Active alcohol or substance abuse; smoking in the last 6 months.
- Patients with evidence of sensitization, i.e. panel reactive antibody (PRA) testing greater than 20%.
- Lack of updated immunizations per current Centers for Disease Control (CDC) guidelines, as well as immunization against hepatitis B, pneumococcus, and influenza (during season), unless medically contraindicated.
- Patients with psychogenic factors, which are judged at psychological evaluation, which make it unsafe to undergo islet transplantation, or which preclude therapeutic compliance.
- Patients with any condition or any circumstance that would make it unsafe to undergo an islet transplant.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
Read the detailed description
- To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;
- To eliminate the incidence of hypoglycemic coma and unawareness by islet cell transplantation;
- To assess long-term function of successful islet cell transplants;
- To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells.
- To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin.
- To assess the ability of exenatide to improve islet survival at time of islet transplantation
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Islet Transplantation
- Keywords
- Islet 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.
Islet TransplantationDrug
Also called islet
Islet Transplantation in subjects with a previous kidney transplant.
| Study group | Role | What they receive |
|---|---|---|
| Islet Transplantation | Experimental | Islet Transplantation in subjects with a previous kidney transplant. Receives: Drug: Islet Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Independence.
Number of Participants who Achieved Insulin Independence at 1 Year
Measured: 1 year
Secondary outcomes (3)
Stimulated C-peptide Greater Than 0.5 ng/ml
Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml
Measured: 1 year
Reduction of Insulin Requirements
Reduction in insulin requirements in those patients who do not achieve insulin independence
Measured: 1year
Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness
Elimination or reduction in the incidence of hypoglycemic coma or unawareness
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startDec 2000
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodolfo Alejandro
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), Diabetes Research Institute Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, Rodolfo Alejandro, University of Miami
- Investigators
- Rodolfo Alejandro, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315588
- Sponsor's protocol ID
- 2000/0329
- Other IDs
- 5R01DK055347, 5R01DK025802
- Status last verified
- Nov 2016
- First submitted
- 14 Apr 2006
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cure P, Pileggi A, Froud T, Messinger S, Faradji RN, Baidal DA, Cardani R, Curry A, Poggioli R, Pugliese A, Betancourt A, Esquenazi V, Ciancio G, Selvaggi G, Burke GW 3rd, Ricordi C, Alejandro R. Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. Transplantation. 2008 Mar 27;85(6):801-12. doi: 10.1097/TP.0b013e318166a27b.
PubMed 18360260Faradji RN, Froud T, Messinger S, Monroy K, Pileggi A, Mineo D, Tharavanij T, Mendez AJ, Ricordi C, Alejandro R. Long-term metabolic and hormonal effects of exenatide on islet transplant recipients with allograft dysfunction. Cell Transplant. 2009;18(10):1247-59. doi: 10.3727/096368909X474456.
PubMed 20003758Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7. doi: 10.1097/TP.0b013e31818a7f45.
PubMed 19005394
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00315588
- Acronym / sponsor ID
- 2000/0329
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Islet Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rodolfo AlejandroUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Health Resources and Services Administration (HRSA), Diabetes Research Institute Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2000
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Apr 2006 (estimated)
- Results
- Posted 12 Apr 2017
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 reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
Detailed description
- To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft;
- To eliminate the incidence of hypoglycemic coma and unawareness by islet cell transplantation;
- To assess long-term function of successful islet cell transplants;
- To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells.
- To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin.
- To assess the ability of exenatide to improve islet survival at time of islet transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Islet Transplantation | Experimental | Drug: Islet TransplantationIslet Transplantation in subjects with a previous kidney transplant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients between 18 and 60 years of age.
- Patients with type 1 diabetes mellitus.
- Patients with a renal transplant that is more than 6 months old.
- Patients with stable renal graft function for the preceding 6 months, i.e. no episodes of rejection and changes in serum creatinine no more than 0.5 mg/dl from baseline.
- Patients who are taking tacrolimus, sirolimus +/- steroids for maintenance immunosuppression for at least 6 months and are tolerating levels satisfactory for islet transplantation without severe complications.
Key exclusion criteria (29 listed)
- Stimulated or basal C-peptide > 0.3 ng/ml.
- Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
- Patients with proteinuria (albuminuria > 300 mg in 24 hours +/- protein) of new onset since kidney transplantation. If proteinuria or albuminuria is thought to originate from the native kidney(s) this will not be an exclusion criterion.
- Patients with corrected creatinine clearance of less than 40.
- Patients weighing more than 80 kg.
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 |
|---|---|---|
| Islet TransplantationAlso: isletIslet Transplantation in subjects with a previous kidney transplant. | Drug | Islet Transplantation |
Primary outcome
Insulin Independence.
Time frame: 1 year
Number of Participants who Achieved Insulin Independence at 1 Year
3 secondary outcomes
Stimulated C-peptide Greater Than 0.5 ng/ml
Time frame: 1 year
Reduction of Insulin Requirements
Time frame: 1year
Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness
Time frame: 1 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18360260Cure P, Pileggi A, Froud T, Messinger S, Faradji RN, Baidal DA, Cardani R, Curry A, Poggioli R, Pugliese A, Betancourt A, Esquenazi V, Ciancio G, Selvaggi G, Burke GW 3rd, Ricordi C, Alejandro R. Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. Transplantation. 2008 Mar 27;85(6):801-12. doi: 10.1097/TP.0b013e318166a27b.
- Derived from this study: PubMed 20003758Faradji RN, Froud T, Messinger S, Monroy K, Pileggi A, Mineo D, Tharavanij T, Mendez AJ, Ricordi C, Alejandro R. Long-term metabolic and hormonal effects of exenatide on islet transplant recipients with allograft dysfunction. Cell Transplant. 2009;18(10):1247-59. doi: 10.3727/096368909X474456.
- Derived from this study: PubMed 19005394Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7. doi: 10.1097/TP.0b013e31818a7f45.
- Research into finding the cure for types 1 and type 2 diabetes.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Rodolfo Alejandro, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Islet Transplantation in people with Diabetes Mellitus, Type 1, run by Rodolfo Alejandro 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 6 inclusion and 29 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 12 Apr 2017. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insulin Independence. (time frame: 1 year). 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 NCT00315588, which also lists 3 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 12 Apr 2017.