NCT01999361

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2009Dec 2028

Study Start

First participant enrolled

January 1, 2009

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

18 years

First QC Date

November 25, 2013

Last Update Submit

March 18, 2026

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • allosensitization after complete islet graft loss

    Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.

    3 years

Study Arms (1)

Myfortic treatment

EXPERIMENTAL

Treatment with Myfortic

Drug: Myfortic

Interventions

MyforticDRUG

treatment with myfortic

Also known as: mycophenolic acid
Myfortic treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

  • Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.

    PMID: 33481552DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Rodolfo Alejandro, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 3, 2013

Study Start

January 1, 2009

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)