A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients (NCT06666283) | Clinical Trial Compass
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
China18 participantsStarted 2025-02-27
Plain-language summary
The study will be a single center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to Diabetic Kidney Disease patients.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female participants, ≥30 years of age at the time of signing the informed consent form.
. BMI (body mass index) 18-30 kg/m².
. Patient has a clinical diagnosis of Type 2 Diabetes Mellitus and is taking at least one type of hypoglycemic drugs, before screening visits, the doses of hypoglycemic drugs, including insulin, need to be stable for at least two weeks..
. Patient must be on a stable dose of angiotensin converting anzyme inhibitior (ACEI) or Angiotensin II receptor blockers (ARB) for at least 4 weeks prior to screening.
. Hemoglobin A1c ≥6.5% but ≤10.5% at the screening visit.
. Estimated GFR ≥30 mL/min/1.73m² but \< 60 mL/min/1.73m² at the screening visit.
. Urinary albumin to creatinine ratio ≥ 30 mg/g at the screening visit.
Exclusion criteria
. Chronic kidney disease other than type 2 diabetic kidney disease.
. Patient receiving corticosteroid immunotherapy or other immunosuppressants (such as calcineurin inhibitors ciclosporin, cyclophosphamide, or mycophenolate mofetil) in the past 3 months before screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Recently having acute kidney injury or received renal surgery within the last 6 months before screening visit, or have received renal transplantation.
. Congestive heart failure classified New York Heart Association (NYHA) class II to IV within the last 3 months before the screening visit.
. Peripheral edema above the ankle level at the screening or randomization visit.
. Confirmed (based on the average of 2 separate resting blood pressure measurements in a sitting position, after at least 5 minutes rest) systolic BP greater than 160 or less than 90 mmHg, and diastolic BP greater than 100 or less than 50 mmHg at screening.
. Myocardial infarction, acute coronary syndrome, stroke or transient ischemic attack, cardiovascular surgery within 6 months prior to the screening visit.
. Abnormalities of ECG parameters and abnormal shape of ECG wave on screening ECG: e.g.
Timeframe: Day 1, Day 14
10
Cav
Timeframe: Day 14
11
Ctrough
Timeframe: Day 3-14
12
Rac
Timeframe: Day 3-14
13
Incidence and severity of adverse events
Timeframe: Day 1-28
14
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation and urinalysis test results