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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01999361

Enrollment

Registered

2013-12-03

Start date

2009-01-01

Completion date

2028-12-01

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Brief summary

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.

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.

Interventions

DRUGMyfortic

treatment with myfortic

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
allosensitization after complete islet graft loss	3 years	Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRodolfo Alejandro, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026