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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999361
• Other study ID #: 20071058
• Status: Recruiting
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Myfortic
treatment with myfortic

Locations

Country	Name	City	State
United States	Diabetes Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rodolfo Alejandro

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Diabetes Research Institute clinical trials