- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285233
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
July 31, 2012 updated by: University of Minnesota
An Open-label Pilot Study of Delayed Mycophenolate Mofetil Instead of Tacrolimus Combined With Anti-thymocyte Globulin, Daclizumab, Etanercept, and Sirolimus in Single-donor, Solitary Islet Allograft Recipients With Type 1 Diabetes
The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin, deletion/inactivation of autoreactive T cells by anti-thymocyte globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
- Phase 1
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
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary islet allotransplant
Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:
- Metabolic lability/instability;
- Reduced awareness of hypoglycemia;
- Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with the diabetes care team);
- Progressive secondary complications.
- Age 18 and older
- Able to give written informed consent
Exclusion Criteria:
- Known hypersensitivity to rabbit proteins.
- Presence of history of panel-reactive anti-HLA antibodies (>10%).
- Insufficient cardiovascular reserve.
- Creatinine clearance <60 mL/min/m2.
- Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease.
- History of malignancy within 5 years.
- Active peptic ulcer disease.
- Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
- Pregnancy or breast-feeding.
- Active infections.
- Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation.
- Negative screen for Epstein-Barr Virus (EBV) by an EBNA method
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening.
- Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications.
- Ongoing substance abuse; drug or alcohol.
- Recent history of noncompliance.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Allogeneic islets of Langerhans transplant
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the incidence and severity of hypoglycemia in type 1 diabetic subjects receiving an islet allotransplant and immunotherapy during the first year posttransplant.
Time Frame: 1 year
|
1 year
|
Assess liver laboratory tests during the first year following intraportal islet allotransplantation.
Time Frame: 1 yr
|
1 yr
|
Assess the incidence, type, and severity of islet transplant-related infectious complications during the first year posttransplant.
Time Frame: 1 year
|
1 year
|
Assess the proportion of recipients who develop alloantibodies directed at donor alloantigens during the first year posttransplant.
Time Frame: 1 year
|
1 year
|
Monitor the incidence, timing, and severity of adverse events as well as their relationship to the islet transplant procedure and additional protocol-regulated treatment products during the first year after islet transplantation.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the proportion of type 1 diabetic subjects receiving delayed mycophenolate mofetil instead of tacrolimus who achieve insulin independence in the first year after transplantation of allogeneic islets.
Time Frame: 1 year
|
1 year
|
Assess the proportion of type 1 diabetic islet allograft recipients with full and partial alloislet function at one year post transplant.
Time Frame: 1 year
|
1 year
|
Assess the glycemic control, insulin secretory responses, and the glucose disposal rate during the first year posttransplant.
Time Frame: 1 year
|
1 year
|
Effect of donor age, pretransplant islet insulin secretory response, # of transplanted islet equivalents, # of transplanted beta cells, pretransplant insulin action, recipient BMI and immunosuppressive therapy on safety and efficacy.
Time Frame: 1 year
|
1 year
|
Assess, in a selected group of islet allotransplant recipients, the autoimmune and alloimmune responses to transplanted islets at intervals during the first year posttransplant.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
September 1, 2000
Primary Completion (Actual)
September 1, 2004
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
January 30, 2006
First Submitted That Met QC Criteria
January 31, 2006
First Posted (Estimate)
February 1, 2006
Study Record Updates
Last Update Posted (Estimate)
August 2, 2012
Last Update Submitted That Met QC Criteria
July 31, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0006M55241
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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