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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tegoprubart
DrugTegoprubart is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. Tegoprubart is thought to work by dampening down our immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidneys, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. Tegoprubart is an experimental agent that is anticipated to prevent rejection without harming the islet cells. This study will test this hypothesis.
Islet Cell Transplant
Biological/VaccineHuman pancreatic islet cells is considered investigational because it is not approved for use in the United States by the Food and Drug Administration (FDA). Participation in this research will last about 5 years. The islet transplant procedure involves inserting a thin, flexible tube called a catheter through a small cut in the upper abdomen. A radiologist uses x-rays and ultrasound to guide the catheter into the portal vein of the liver where the islet cells are delivered. This study of islet transplantation will test to see if islet transplantation is safe and effective; performing this study will help us find if this new medication Tegoprubart, combined with either MPA or everolimus and other medication the investigators have been using routinely so far, would protect sufficiently islet transplant from the destruction by the immune system, allowing participants to stop insulin and have improved blood glucose control.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: TEGOPRUBART WITH EVEROLIMUSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants who are achieved Optimal outcomes according to Igls criteria
Assessed by continuous glucose monitoring (CGM) for insulin independence, HbA1c\<7.0 (53 mmol/mol), and no severe hypoglycemic episodes (SHE).
Time frame
1 year post-transplant2
Number of participants who are achieved Good outcomes according to Igls criteria
Assessed by CGM for some insulin support, improved blood glucose control from baseline (pre-transplant), and with SHE.
Time frame
1 year post-transplantSecondary outcomes
1
Number of participants who achieved insulin independence
Evaluated by continuous glucose monitoring.
Time frame
1 year post-transplant, and once a year thereafter until end of study2
Number of participants with no SHE and with HbA1c ≤6.5 (48 mmol/mol)
Assessed by patient reports of SHEs and HbA1c lab value.
Time frame
From 1 year post-transplant through end of study participation, assessed annually3
Number of participants with no SHE and with HbA1c ≤7.0 (53 mmol/mol)
Assessed by patient reports of SHEs and HbA1c lab value.
Time frame
From 1-year post-transplant through end of study participation, assessed annually4
Number of participants with preserved renal function (maintain the same stage of CKD)
Measurement will be based on the stages of Chronic Kidney Disease, the investigators will check if the patient maintains the same stage, and will upgrade the stage or downgrade Stages based on eGFR.
Time frame
From 1-year post-transplant through end of study participation, assessed annuallySponsors and contacts
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Source ClinicalTrials.gov