Prevention of de Novo Allosensitization in Islet Transpla... | NCT01999361

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

NCT01999361

Sponsor

Rodolfo Alejandro

Status

Recruiting

Last Update Posted

Mar 23, 2026Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Type 1 Diabetes Mellitus

Interventions

Myfortic

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2027Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Nov 25, 2013

First Submission Date that Met QC Criteria

Nov 25, 2013

First Posted Date

Dec 3, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Label	Type	Description	Intervention Names
Myfortic treatment	Experimental	Treatment with Myfortic	Drug: Myfortic

Name	Type	Description	Arm Group Labels	Other Names
Myfortic	Drug	treatment with myfortic	Myfortic treatment	mycophenolic acid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Rodolfo Alejandro, MD	University of Miami	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Diabetes Research Institute	Recruiting	Miami	Florida	33136	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33481552	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals