Phase 2 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years old.
• People who have had Type 1 diabetes for at least 5 years, with the condition first starting before age 40.
• People who are able to understand and agree to take part in the study on their own behalf.
• People who are able to follow all study procedures, including wearing a continuous glucose monitor (a small device that tracks blood sugar levels throughout the day).
• People who are already managing their diabetes with an insulin pump or multiple daily injections, but who are still having serious unexplained low blood sugar episodes despite this treatment.
• People whose HbA1c blood sugar level (a measure of average blood sugar over roughly 3 months) is between 6.5% and 9.5%.
• People whose pancreas produces little to no insulin of its own, confirmed by a specific test called a mixed-meal tolerance test.
• People with mild to moderate kidney disease, specifically classified as stage 1, 2, or 3a (confirm with trial site).
• People who have reduced awareness of low blood sugar episodes, confirmed by meeting at least one of several specific clinical measures — such as a certain score on a hypoglycemia awareness questionnaire, a pattern of low blood sugar readings on their continuous glucose monitor, a certain score on the Clarke test, or having had two or more severe low blood sugar episodes requiring outside help in the past year (confirm with trial site for which measure applies).
• Female participants who are surgically sterile, post-menopausal, or who have a negative pregnancy test at the start of the study and agree to use two highly effective forms of contraception throughout the study, during any immunosuppressive treatment after the study, and for 90 days after the last dose of the study drug.
• Male participants who agree to use two highly effective forms of contraception throughout the study and for 90 days after the last dose of the study drug, and who agree not to donate sperm during this period.

Who may not be able to join:

• People with a body mass index (BMI) over 30.
• People who weigh 40 kg (approximately 88 pounds) or less.
• People whose daily insulin needs are more than 60 units or fewer than 15 units per day.
• People with untreated and uncontrolled advanced diabetic eye disease affecting the retina.
• People with high blood pressure above 140/90 mmHg.
• People with moderate-to-severe kidney disease, classified as stage 3b or higher.
• People with a high level of protein in their urine indicating significant kidney damage (a condition called macroalbuminuria).
• Female participants who are pregnant, breastfeeding, or unwilling to use effective contraception during the study and for 90 days after the last dose. Male participants who intend to father a child during the study or within 90 days after the last dose, or who are unwilling to use effective contraception.
• People with a history of cancer, except for certain fully removed skin cancers (squamous cell or basal cell carcinoma).
• People with a history of blood clots, a known condition that makes blood clotting more likely, or who need long-term blood-thinning medication (people who take only aspirin may still be eligible; cases involving a previously clotted IV line may be considered at the investigator's discretion).
• People who require long-term use of steroid medications for a medical condition, unless it is for a hormone replacement condition such as Addison's disease.
• People with an active ongoing infection, including tuberculosis, HIV, hepatitis B, or hepatitis C, even if there are no obvious symptoms but blood tests show signs of infection.
• People who have had certain serious fungal infections (aspergillus, histoplasmosis, or coccidioidomycosis) within the past year.
• People whose blood tests show they have never been exposed to the Epstein-Barr virus (the virus that causes glandular fever).
• People currently taking immunosuppressive medications or certain immune-modifying drugs, including biologics, JAK inhibitors, or systemic corticosteroids (confirm full list with trial site).
• People whose blood tests show a high level of pre-formed antibodies that could attack transplanted tissue (PRA over 40%) (confirm with trial site).
• People who have previously had an organ transplant, except for a failed pancreas or islet cell transplant.
• People with persistently elevated liver enzyme levels significantly above the normal range, or elevated bilirubin levels.
• People who have previously received experimental cell or gene therapy, or who have taken part in another experimental drug study within the past 30 days or within 5 half-lives of that drug (whichever is longer).
• People with a history of substance misuse in the past 6 months.
• People with serious heart or cardiovascular disease, including a history of stroke, a heart attack in the past 6 months, evidence of reduced blood flow to the heart on a cardiac test in the past year, or significantly reduced heart pumping function.
• People with high cholesterol or high triglycerides (blood fats) that remain significantly elevated despite medical treatment.
• People with abnormally low levels of certain blood cells — including red blood cells, a type of white blood cell called lymphocytes, another type called neutrophils, or platelets — unless a specialist determines there is no additional risk (confirm with trial site).
• People who have received a live vaccine within the past 2 months before the study screening visit.
• People who have previously been treated with the study drug (Tegoprubart) or any similar medication targeting the same immune pathway.

Important: Always verify eligibility with the trial site directly before applying.