Preventing new immune responses in islet transplant patients after graft loss

Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

This study is testing if switching islet transplant patients who lost their graft to a different medication can help prevent their immune system from reacting negatively to future transplants.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT01999361 on ClinicalTrials.gov

What this trial studies

This study focuses on islet transplant recipients who have experienced complete graft loss, defined by low stimulated c-peptide levels. Participants will discontinue their current immunosuppressive medications and switch to Myfortic® monotherapy for a duration of two years. Following this period, the Myfortic® treatment will be gradually reduced, and patients will be monitored for any signs of sensitization through panel reactive antibody levels over the next twelve months. The goal is to assess whether this approach can prevent new immune responses that complicate future transplants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who have had at least one islet transplant and have experienced complete graft loss.

Not a fit: Patients with untreated severe hyperlipidemia, active infections, or a history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help prevent new immune responses in islet transplant recipients, potentially improving their chances for future transplants.

How similar studies have performed: While similar approaches have been explored, this specific method of using Myfortic® monotherapy after complete graft loss is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients age 18-70 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
5. History of at least one islet transplant.
6. Stimulated C-peptide \<0.3 ng/ml.

Exclusion Criteria:

1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
2. For female participants: Positive pregnancy test or presently breast-feeding.
3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
5. Known active alcohol or substance abuse.
6. 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%.
7. 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.
8. Evidence of inter-current infection.
9. Active peptic ulcer disease
10. History on non-adherence to prescribed regimens including immunosuppression.
11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.

Where this trial is running

Miami, Florida

• Diabetes Research Institute — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Rodolfo Alejandro, MD — University of Miami

Conditions Type 1 Diabetes Mellitus