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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Myfortic

About this trial

This is an interventional prevention trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Diabetes Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myfortic treatment

Arm Description

Treatment with Myfortic

Outcomes

Primary Outcome Measures

allosensitization after complete islet graft loss

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01999361

First Posted

November 25, 2013

Last Updated

February 24, 2023

Sponsor

Rodolfo Alejandro

1. Study Identification

Unique Protocol Identification Number

NCT01999361

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rodolfo Alejandro

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Myfortic treatment

Arm Type

Experimental

Arm Description

Treatment with Myfortic

Intervention Type

Drug

Intervention Name(s)

Myfortic

Other Intervention Name(s)

mycophenolic acid

Intervention Description

treatment with myfortic

Primary Outcome Measure Information:

Title

allosensitization after complete islet graft loss

Description

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

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodolfo Alejandro, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Research Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rodolfo Alejandro, MD

Phone

305-243-5321

islet@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Ana M Alvarez, APRN

Phone

305 243-3389

axa383@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Rodolfo Alejandro, MD

First Name & Middle Initial & Last Name & Degree

David A Baidal, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33481552

Citation

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.

Results Reference

derived

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

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