Diabete Type 1Phase 1/2NCT07592000
Breakthrough - T1DM and Chronic Kidney Disease
A Phase 1/2 study testing Tegoprubart and Islet Cell Transplant in people with Diabete Type 1 and Chronic Kidney Disease, run by University of Chicago at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabete Type 1, Chronic Kidney Disease
- What is being tested?
- Tegoprubart and Islet Cell Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2027to 31 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Body mass index (BMI) >30 kg/m2.
- Weight ≤40 kg.
- Insulin requirement >60units/day or <15 units/day.
- Untreated and uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg.
- Chronic kidney disease stage 3b or above.
Show all 27Show fewer
- Diagnosis of macroalbuminuria (ACR>300 mg/g creatinine).
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male participants: intent to procreate during the duration of the study or within 90 days after discontinuation or unwillingness to use effective measures of contraception.
- History of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
- History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation:
- Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable state.
- Patients on aspirin are allowed.
- Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease.
- Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of infection is exclusionary.
- Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening.
- Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination.
- Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, JAK inhibitors, S1P receptor agonists, azathioprine, 6- MP, or systemic corticosteroids.
- Baseline PRA over 40%
- Previous organ transplant (except failed pancreas or islet transplant)
- Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin >1.5 ULN.
- Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer.
- History of substance abuse within the past 6 months.
- Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d) left ventricular ejection fraction<30%.
- Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol >130 mg/dL and/ or triglycerides >200 mg/dL.
- Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). Participants with lymphopenia are allowed if the Principal Investigator determines there is no additional risk and obtains clearance from a hematologist.
- Administration of live attenuated vaccine(s) within 2 months of Screening.
- Any previous treatment with Tegoprubart or any other anti-CD40L therapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Grange - Islet Cell Transplant Program Manager contact
Minelly Escobedo contact
United States2 sites, 2 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Hannah Gilkey, 000-000-0000, hannah.gilkey@bsd.uchicago.edu
Piotr Witkowski
- Recruiting
Diabetes Research Institute, University of Miami
Miami, Florida, 33136
Camillo Ricordi, M.D, 305-243-3781, islet@med.miami.edu
Natalia Padilla, 1-305-243-5321, islet@med.miami.edu
About this study
Official title: Multicenter, Phase 1/2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islet Transplantation in Patients With T1DM and Chronic Kidney Disease
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:
Read more
- 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).
Read the detailed description
This study is funded by Breakthrough T1D (formerly the Juvenile Diabetes Research Foundation) and Emerald Clinical Trials will be acting as the clinical research organization (CRO) for this study, overseeing data integrity, compliance and monitoring clinical trial activity. They will help with development of all regulatory and fully supporting University of Miami.
Islet cells are the specialized cells in the pancreas that produce insulin. In this study, islet cells will be collected from the pancreas of a deceased organ donor in a special laboratory at University of Chicago and then transplanted into the body at the University of Chicago hospital. The goal of this study is to see whether these transplanted islet cells can take over insulin production for the body. The study team will evaluate how well make insulin and how well controlled blood sugar is after the transplant. Islet transplantation has been performed and continuously optimized under clinical studies at the University of Chicago for the past 20 years. During this time, several new, potentially more effective and less toxic combinations of immunosuppressive medications have been evaluated. More recently, Tegoprubart has been tested in a small number of patients with T1D and only mild kidney dysfunction, in combination with mycophenolic acid (Myfortic). Given the promising preliminary results, Tegoprubart is now being studied in pancreatic cell transplantation together with either mycophenolic acid (MPA) or everolimus as part of the immunosuppressive regimen also in patients, who were previously ineligible for islet transplantation due to more advanced kidney dysfunction.
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 provider has been using routinely so far, would protect sufficiently islet transplant from the destruction by the immune system, allowing to stop insulin and have improved blood glucose control. At the same time, the providers will observe if these therapies are safe and other patients participating in the study.
Because these islet cells came from another person, the immune system may recognize them as foreign and attack them. Standard immunosuppressive medicines (Anti-thymocyte globulin [ATG] or Basiliximab and Etanercept) with either MPA or everolimus will be used to help prevent the body from attacking the transplanted islet cells. Immunosuppressive medicines may also be called anti-rejection medicines. Tegoprubart will be given in combination with these standard immunosuppressive medicines to test whether the investigational drug is safe, tolerable, and efficacious. The effect of the combination of Tegoprubart with other immunosuppressant medications has not been previously tested.
Tegoprubart is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by their 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. Early results from a recent kidney transplant study using Tegoprubart with Myfortic show that Tegoprubart appears to be less harmful to the insulin-producing cells, the kidneys, and the nervous system compared with tacrolimus and is comparable in prevention of rejection and risk of infectious and developing blood clots in blood vessels.
The Tegoprubart for this study has been provided by Eledon Pharmaceuticals.
- Conditions
- Diabete Type 1, Chronic Kidney Disease
- Being tested
- Tegoprubart, Islet Cell Transplant
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprubartDrug
Tegoprubart 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 TransplantBiological
Human 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.
| Study group | Role | What they receive |
|---|---|---|
| TEGOPRUBART WITH EVEROLIMUS | Experimental | maintenance immunosupression consists of Tegoprubart and Everolimus Receives: Drug: Tegoprubart; Biological: Islet Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year post-transplant
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.
Measured: 1 year post-transplant
Secondary outcomes (7)
Number of participants who achieved insulin independence
Evaluated by continuous glucose monitoring.
Measured: 1 year post-transplant, and once a year thereafter until end of study
Number of participants with no SHE and with HbA1c ≤6.5 (48 mmol/mol)
Assessed by patient reports of SHEs and HbA1c lab value.
Measured: From 1 year post-transplant through end of study participation, assessed annually
Number of participants with no SHE and with HbA1c ≤7.0 (53 mmol/mol)
Assessed by patient reports of SHEs and HbA1c lab value.
Measured: From 1-year post-transplant through end of study participation, assessed annually
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.
Measured: From 1-year post-transplant through end of study participation, assessed annually
Number of participants who developed progression of albuminuria (no albuminuria to microalbuminuria, microalbuminuria to macroalbuminuria)
Assessed by albumin lab values in relation to pre-transplant value.
Measured: From 1-year post-transplant through end of study participation, assessed annually.
Number of participants with no progression of albuminuria
Assessed by albumin lab values in relation to pre-transplant value.
Measured: From 1-year post-transplant through end of study participation, assessed annually.
Changes in estimated glomerular filtration rate (eGFR) post-transplant.
Assessed by eGFR lab value in relation to pre-transplant value.
Measured: 6 months and 12 months after last islet transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start29 Apr 2027 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Breakthrough T1D, University of Miami
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592000
- Sponsor's protocol ID
- IRB25-1433
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Phase 1/2 Pilot Study of Safety and Efficacy Assessment of Tegoprubart and Calcineurin Inhibitors- Free Immunosuppression Therapy for Pancreatic Islet Transplantation in Patients With T1DM and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07592000
- Acronym / sponsor ID
- IRB25-1433
- Conditions
- Diabete Type 1, Chronic Kidney Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Breakthrough T1D, University of Miami
- Study start
- 29 Apr 2027 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is funded by Breakthrough T1D (formerly the Juvenile Diabetes Research Foundation) and Emerald Clinical Trials will be acting as the clinical research organization (CRO) for this study, overseeing data integrity, compliance and monitoring clinical trial activity. They will help with development of all regulatory and fully supporting University of Miami.
Islet cells are the specialized cells in the pancreas that produce insulin. In this study, islet cells will be collected from the pancreas of a deceased organ donor in a special laboratory at University of Chicago and then transplanted into the body at the University of Chicago hospital. The goal of this study is to see whether these transplanted islet cells can take over insulin production for the body. The study team will evaluate how well make insulin and how well controlled blood sugar is after the transplant. Islet transplantation has been performed and continuously optimized under clinical studies at the University of Chicago for the past 20 years. During this time, several new, potentially more effective and less toxic combinations of immunosuppressive medications have been evaluated. More recently, Tegoprubart has been tested in a small number of patients with T1D and only mild kidney dysfunction, in combination with mycophenolic acid (Myfortic). Given the promising preliminary results, Tegoprubart is now being studied in pancreatic cell transplantation together with either mycophenolic acid (MPA) or everolimus as part of the immunosuppressive regimen also in patients, who were previously ineligible for islet transplantation due to more advanced kidney dysfunction.
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 provider has been using routinely so far, would protect sufficiently islet transplant from the destruction by the immune system, allowing to stop insulin and have improved blood glucose control. At the same time, the providers will observe if these therapies are safe and other patients participating in the study.
Because these islet cells came from another person, the immune system may recognize them as foreign and attack them. Standard immunosuppressive medicines (Anti-thymocyte globulin [ATG] or Basiliximab and Etanercept) with either MPA or everolimus will be used to help prevent the body from attacking the transplanted islet cells. Immunosuppressive medicines may also be called anti-rejection medicines. Tegoprubart will be given in combination with these standard immunosuppressive medicines to test whether the investigational drug is safe, tolerable, and efficacious. The effect of the combination of Tegoprubart with other immunosuppressant medications has not been previously tested.
Tegoprubart is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by their 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. Early results from a recent kidney transplant study using Tegoprubart with Myfortic show that Tegoprubart appears to be less harmful to the insulin-producing cells, the kidneys, and the nervous system compared with tacrolimus and is comparable in prevention of rejection and risk of infectious and developing blood clots in blood vessels.
The Tegoprubart for this study has been provided by Eledon Pharmaceuticals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEGOPRUBART WITH EVEROLIMUS | Experimental | Drug: Tegoprubart, Biological: Islet Cell Transplantmaintenance immunosupression consists of Tegoprubart and Everolimus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (27 listed)
- Body mass index (BMI) >30 kg/m2.
- Weight ≤40 kg.
- Insulin requirement >60units/day or <15 units/day.
- Untreated and uncontrolled proliferative diabetic retinopathy.
- Blood pressure: systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegoprubartTegoprubart 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. | Drug | TEGOPRUBART WITH EVEROLIMUS |
| Islet Cell TransplantHuman 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. | Biological | TEGOPRUBART WITH EVEROLIMUS |
Primary outcome
Number of participants who are achieved Optimal outcomes according to Igls criteria
Time frame: 1 year post-transplant
Assessed by continuous glucose monitoring (CGM) for insulin independence, HbA1c<7.0 (53 mmol/mol), and no severe hypoglycemic episodes (SHE).
Number of participants who are achieved Good outcomes according to Igls criteria
Time frame: 1 year post-transplant
Assessed by CGM for some insulin support, improved blood glucose control from baseline (pre-transplant), and with SHE.
7 secondary outcomes
Number of participants who achieved insulin independence
Time frame: 1 year post-transplant, and once a year thereafter until end of study
Number of participants with no SHE and with HbA1c ≤6.5 (48 mmol/mol)
Time frame: From 1 year post-transplant through end of study participation, assessed annually
Number of participants with no SHE and with HbA1c ≤7.0 (53 mmol/mol)
Time frame: From 1-year post-transplant through end of study participation, assessed annually
Number of participants with preserved renal function (maintain the same stage of CKD)
Time frame: From 1-year post-transplant through end of study participation, assessed annually
Number of participants who developed progression of albuminuria (no albuminuria to microalbuminuria, microalbuminuria to macroalbuminuria)
Time frame: From 1-year post-transplant through end of study participation, assessed annually.
Number of participants with no progression of albuminuria
Time frame: From 1-year post-transplant through end of study participation, assessed annually.
Changes in estimated glomerular filtration rate (eGFR) post-transplant.
Time frame: 6 months and 12 months after last islet transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Type 1
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
Not yet recruitingPhase 1/2
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Diabete Mellitus, Diabete Type 1
RecruitingObservational study
Strategy For Assessing The Risk Of Type 1 Diabetes In Pediatric Celiac Patients
Diabete Type 1
Not yet recruiting
Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes
Diabetes Type 1
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Grange - Islet Cell Transplant Program Manager contact
Minelly Escobedo contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tegoprubart and Islet Cell Transplant in people with Diabete Type 1 and Chronic Kidney Disease, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Grange - Islet Cell Transplant Program Manager (773-702-9771, Alexandra.Grange@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are achieved Optimal outcomes according to Igls criteria (time frame: 1 year post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.