- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315588
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
February 28, 2017 updated by: Rodolfo Alejandro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- Diabetes Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Islet Transplantation
Islet Transplantation in subjects with a previous kidney transplant.
|
Islet Transplantation in subjects with a previous kidney transplant.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Independence.
Time Frame: 1 year
|
Number of Participants who Achieved Insulin Independence at 1 Year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulated C-peptide Greater Than 0.5 ng/ml
Time Frame: 1 year
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Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml
|
1 year
|
Reduction of Insulin Requirements
Time Frame: 1year
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Reduction in insulin requirements in those patients who do not achieve insulin independence
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1year
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Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness
Time Frame: 1 years
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Elimination or reduction in the incidence of hypoglycemic coma or unawareness
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1 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rodolfo Alejandro, M.D., University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tharavanij 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.
- Faradji 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2000
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
April 14, 2006
First Submitted That Met QC Criteria
April 14, 2006
First Posted (Estimate)
April 18, 2006
Study Record Updates
Last Update Posted (Actual)
April 12, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000/0329
- 5R01DK055347 (U.S. NIH Grant/Contract)
- 5R01DK025802 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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