Breakthrough - T1DM and Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Chicago
About this trial
Single arm- subject treated with Tegoprubart and everolimus.
The purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components:
* An investigational drug called Tegoprubart and * Human pancreatic islet cells
Both Tegoprubart and human pancreatic islet cells are considered investigational because they are not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years.
Assess safety, tolerability, and efficacy of transplanted islet cells and immunomodulation with Tegoprubart in combination with anti-thymocyte globulin (ATG), etanercept and with everolimus in adults with brittle T1D and chronic kidney disease (stage 2-3a).
Eligibility criteria
Qualifiers
Subjects 18-70 years of age.
A diagnosis of T1D ≥5 years with onset of disease at <40 years of age.
Ability to provide informed consent.
Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM).
Disqualifiers
Body mass index (BMI) >30 kg/m2.
Weight ≤40 kg.
Insulin requirement >60units/day or <15 units/day.
Untreated and uncontrolled proliferative diabetic retinopathy.
Trial design
Treatments tested in this trial
- Tegoprubart
- Islet Cell Transplant
Treatment groups
No treatment groups listed
Sponsors and collaborators
University of Chicago
Lead sponsor
Breakthrough T1D
Collaborator
Source ClinicalTrials.gov