Phase 1 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 55 or older, of any gender
• People who are willing and able to sign a written consent form to take part in the study
• People with chronic kidney disease (CKD) at a moderate-to-severe stage (stage 3b–5), who are not currently on dialysis — or, for the comparison group, people with normal kidney function (confirm with trial site which group applies)
• People who are otherwise in a stable, overall good health condition, based on medical history, physical check-up, blood tests, and a heart tracing (ECG)
• People with a body weight in a healthy range (BMI between 19 and 40); people below this range may still be considered at the doctor's discretion
• People with blood pressure and resting heart rate within specific ranges at the screening visit, whether or not they are already taking blood pressure medication at a stable dose
• People who do not currently smoke and have not smoked in the past 6 months
• People who have been on stable doses of their regular medications for at least 30 days before joining, with doses expected to stay the same throughout the study
• Male participants who agree not to donate sperm during the study and for 12 months after the last dose of the study drug
• Male participants who agree to use highly effective contraception from enrollment until at least 2 months after the last dose
• Female participants who are not pregnant, not breastfeeding, and who are either postmenopausal for at least 1 year, have had a surgical procedure that prevents pregnancy (for at least 3 months), or agree to use highly effective double-barrier contraception for a specified period before and after the study

Who may not be able to join:

• People who have donated or received a significant amount of blood or blood products (more than 450 mL) within the past 3 months
• People who have taken another experimental (investigational) drug within the past month before screening
• People who regularly use opioid pain medications (such as morphine or codeine)
• People who are currently taking, or plan to take, certain prescription or over-the-counter medicines that affect the way the body breaks down drugs — including some antifungals, antibiotics, anticonvulsants, and certain heart or antidepressant medications (confirm specific medications with trial site)
• People who regularly consume certain foods or supplements known to affect how the body processes medications, such as St. John's Wort or grapefruit juice
• People who have difficulty swallowing tablets or capsules
• People with active cancer, a high risk of cancer returning, or a personal or close family history that suggests an elevated cancer risk in the doctor's opinion
• People with a history of conditions affecting the hormone-regulating glands (hypothalamus, pituitary, adrenal, or reproductive glands) (confirm with trial site)
• People with active or recent stomach, digestive, liver, or blood-clotting disorders within the past month
• People with unstable heart or lung conditions, including a recent heart attack within the past 6 months
• People with severe heart failure where the heart is pumping at very low capacity
• People with serious heart or lung conditions that limit exercise, including severe heart valve disease, chest pain on exertion, or a major cardiovascular event in the past 6 months
• People with a history of unstable irregular heartbeat (arrhythmia)
• People with significantly abnormal potassium levels in their blood
• People with serious mental health or social difficulties, as assessed by the study doctor
• People with current significant cognitive impairment or major psychiatric conditions that could affect their ability to follow study procedures
• People who have had a bacterial, fungal, or viral infection requiring treatment with antibiotics or antiviral medication within the past month
• People who currently have or recently had COVID-19 (confirmed or suspected) — specific timeframes apply depending on severity (confirm with trial site)
• People who have received a COVID-19 vaccine within 4 weeks of joining, or who plan to receive one during the study
• People with a history of active Hepatitis A, B, C, or HIV
• People who test positive for drugs or alcohol at screening or on admission (note: a low level of cannabis use may be considered on a case-by-case basis by the study doctor)

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