Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT01999361

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

Led by Rodolfo Alejandro · Updated on 2026-03-23

18

Participants Needed

1

Research Sites

1039 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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 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, SGPT, alkaline phosphatase or total bilirubin) greater than 1.5 times normal upper limits.
  • Evidence of inter-current infection.
  • Active peptic ulcer disease.
  • History of non-adherence to prescribed regimens including immunosuppression.
  • PRA ≥ 50% or evidence of significant sensitization as determined by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Diabetes Research Institute

Miami, Florida, United States, 33136

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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