Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
March 18, 2026 updated by: Rodolfo Alejandro
Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
Study Overview
Detailed Description
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e.
sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter.
After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Not Applicable
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
-
Miami, Florida, United States, 33136
- Recruiting
- Diabetes Research Institute
-
Contact:
- Ana M Alvarez, APRN
- Phone Number: 305 243-3389
- Email: axa383@med.miami.edu
-
Sub-Investigator:
- David A Baidal, MD
-
Contact:
- Rodolfo Alejandro, MD
- Phone Number: 305-243-5321
- Email: islet@med.miami.edu
-
Principal Investigator:
- Rodolfo Alejandro, MD
-
-
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male and female patients age 18-70 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
- History of at least one islet transplant.
- Stimulated C-peptide <0.3 ng/ml.
Exclusion Criteria:
- Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
- For female participants: Positive pregnancy test or presently breast-feeding.
- History of active infection including hepatitis B, hepatitis C, HIV, or TB.
- Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
- Known active alcohol or substance abuse.
- Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction <30%.
- History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
- Evidence of inter-current infection.
- Active peptic ulcer disease
- History on non-adherence to prescribed regimens including immunosuppression.
- PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myfortic treatment
Treatment with Myfortic
|
treatment with myfortic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
allosensitization after complete islet graft loss
Time Frame: 3 years
|
Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodolfo Alejandro, MD, 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.
Helpful Links
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
January 1, 2009
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
November 25, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimated)
December 3, 2013
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20071058
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.