Phase 2 Heart Disease Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older who have received a kidney transplant (from either a living or deceased donor) between 1 and 10 years ago
• People whose transplanted kidney is working at a stable and consistent level, as determined by their doctor
• People whose transplanted kidney is functioning at a level of at least 25 mL/min/1.73m² (a specific measurement of kidney function — confirm with trial site)
• People who have a urine test result showing a certain level of protein leakage (albumin-to-creatinine ratio of 30 or above — confirm with trial site)
• People who are able to give their own informed consent, or who have a legally authorised representative who can do so on their behalf
• Women who cannot become pregnant (for example, due to surgical procedures or being postmenopausal) do not need pregnancy testing or additional contraception requirements
• Women who could potentially become pregnant, provided they test negative for pregnancy at their first visit and agree to use a reliable form of contraception throughout the study and for 8 weeks after the last dose

Additional criteria for people joining the kidney biopsy part of the study:

• People who are willing to have two kidney biopsies — one at the start and one after 12 months
• People who are able to safely stop blood-thinning medications before the biopsy
• People who have no known conditions that cause unusual bleeding
• People whose blood counts and clotting results fall within safe ranges on the day of the biopsy (confirm specific values with trial site)
• People with a body mass index (a measure of body weight relative to height) below 40
• People whose blood pressure is below 160/90 on the day of the biopsy

Who may not be able to join:

• People with a documented history of certain kidney diseases that have returned after transplant, including lupus nephritis, ANCA vasculitis, or certain types of kidney inflammation (confirm with trial site)
• People who have had a transplant of any solid organ other than a kidney
• People who needed dialysis due to sudden kidney failure in the 6 months before the screening visit
• People with high blood pressure that is not well controlled (sitting blood pressure of 180 or higher on the top number, or 100 or higher on the bottom number)
• People who have a medical reason to take a specific type of blood pressure or heart medication called a steroidal MRA (confirm with trial site)
• People whose urine protein leakage is very high (albumin-to-creatinine ratio above 3,500 — confirm with trial site, as this may be re-checked)
• People who have had a serious heart or blood vessel event in the 3 months before screening, such as a heart attack, stroke, heart failure requiring urgent care, a mini-stroke (TIA), a blood clot in the lungs, or planned heart bypass surgery
• People who had a planned heart procedure (coronary stenting) in the month before screening
• People with a known allergy or sensitivity to the study medication
• People with Addison's disease (a condition affecting the adrenal glands)
• People with severe liver disease (classified as Child-Pugh C — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant
• People currently taking certain medications — including spironolactone, eplerenone, sacubitril/valsartan, or potassium-sparing water tablets — that cannot be stopped at least 2 weeks before screening
• People taking both ACE inhibitors and ARBs (two types of blood pressure medications) at the same time, unless one can be stopped at least 2 weeks before screening
• People taking certain strong medications that affect how the liver processes drugs (CYP3A4 inhibitors or inducers — confirm with trial site), unless stopped at least 7 days before the study begins
• People with certain medical implants such as some pacemakers, electronic devices, eye shrapnel, or certain types of aneurysm clips may not be able to participate in the MRI part of the study
• People whose personal circumstances, health history, or other conditions might — in the opinion of the study doctor — affect their ability to safely take part
• People who have a close personal or professional connection to the trial site or research team
• People who are currently participating in another interventional clinical trial, or who have done so within 30 days before joining this study

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