RECRUITING

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

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Conditions

Type 1 Diabetes Mellitus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2009-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01999361

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female patients age 18-70 years of age.
  2. 2. Ability to provide written informed consent.
  3. 3. Mentally stable and able to comply with the procedures of the study protocol.
  4. 4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
  5. 5. History of at least one islet transplant.
  6. 6. Stimulated C-peptide \<0.3 ng/ml.
  1. 1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
  2. 2. For female participants: Positive pregnancy test or presently breast-feeding.
  3. 3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
  4. 4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
  5. 5. Known active alcohol or substance abuse.
  6. 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. 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. 8. Evidence of inter-current infection.
  9. 9. Active peptic ulcer disease
  10. 10. History on non-adherence to prescribed regimens including immunosuppression.
  11. 11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.

Contacts and Locations

Principal Investigator

Rodolfo Alejandro, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

Diabetes Research Institute
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Rodolfo Alejandro

  • Rodolfo Alejandro, MD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Registration Dates

Study Start Date2009-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2009-01
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus