GBP-213 in Patients With Autosomal Dominant Polycystic Kidney Disease

Prior treatment

• Use of a vasopressin V2 receptor antagonist (e.g., tolvaptan), somatostatin analog (e.g., lanreotide, pasireotide, octreotide), mTOR inhibitor (e.g., everolimus, sirolimus), or any investigational drug within 30 days or 5 half-lives before dosing, whichever is longer.
• Any of the following cardiovascular or cerebrovascular events within 6 months before dosing: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association class III or IV heart failure, stroke, etc.

Other illness

• Diagnosis of renal cystic disease due to other causes, such as autosomal recessive polycystic kidney disease, tuberous sclerosis complex, medullary cystic kidney disease, simple renal cysts, acquired cystic kidney disease, etc.
• Other severe or chronic hepatic or renal diseases in addition to ADPKD, such as glomerular or tubulointerstitial disease, end-stage renal disease, viral/alcoholic hepatitis, active autoimmune hepatitis, liver cancer, renal cancer, acute kidney injury, cirrhosis, etc.

• Age 18 to 65 years inclusive at the time of signing the ICF, regardless of sex.
• Clinically diagnosed with ADPKD
• Meets criteria for rapidly progressive ADPKD.
• 100≥eGFR≥30mL/min/1.73m²
• Understands the study procedures and voluntarily signs the written informed consent form.