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Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at preventing new immune reactions to donor tissue after an islet transplant has completely stopped working. Islets are cells that make insulin. The study is for adults ages 18–70 who have had an islet transplant.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–70 years old.
  • You can give written consent to join the study.
  • You are mentally stable and able to follow study steps.
  • You take medicines that lower immune activity, or your transplant care plan calls for stopping them.
  • You have had at least one islet transplant.
  • Your stimulated C-peptide level is below 0.3 ng/mL. This test measures how much insulin your body makes.

Who can't join

  • You have untreated very high blood fat levels, obesity, or high blood pressure that does not respond to treatment.
  • You have a positive pregnancy test or are breastfeeding.
  • You have a history of active infection, including hepatitis B, hepatitis C, HIV, or TB, or signs of a current infection.
  • You have had cancer, except basal or squamous cell skin cancer that was fully removed.
  • You currently misuse alcohol or drugs, or have a history of not following prescribed treatment, including immune-lowering medicines.
  • You have severe heart disease: a heart attack in the past 6 months, poor heart blood flow on testing in the past year, or a heart pumping measure below 30%.
  • You have an active stomach or upper-gut ulcer, or ongoing liver blood test levels more than 1.5 times the upper normal limit.
  • Your PRA test is 50% or higher, or the study doctor finds a strong immune reaction to donor tissue. PRA measures antibodies that may attack donor tissue.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL