Autosomal dominant polycystic kidney disease
Conditions
Interventions
Experimental group:Tolvaptan tablets combined with injectable octreotide microspheres. Tolvaptan tablets (Zhejiang Daitou Pharmaceutical, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) for oral us
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign an informed consent form to voluntarily join this study; 2. Age > 18 years and = 3; (2) 40-59 years, number of renal cysts on each side >= 2; over 60 years, number of renal cysts on each side >= 5; (3) CT/MRI diagnostic criteria: total number of renal cysts >= 10; (4) For patients without a clear family history of ADPKD or atypical renal imaging findings, diagnosis via PKD gene sequencing, with PKD1 or PKD2 gene mutations (85%); 5. Rapidly progressing ADPKD, meeting any 3 of the following 6 criteria can confirm the diagnosis of rapidly progressing ADPKD: (1) A patient in a typical ADPKD family progresses to ESKD before age 55; (2) Hypertension requiring medication, cyst bleeding, or infection occurs before age 35; (3) Estimated glomerular filtration rate (eGFR) decreases > 2.5 ml.min-1.(1.73m2)-1 annually for 5 consecutive years; (4) Annual total kidney volume (TKV) growth rate >= 5%;(5) Mayo classification types 1C to 1E;(6) PKD1 truncating variants.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to tolvaptan or its derivatives; 2. Patients with abnormal liver function, hypovolemia or hypernatremia; 3. Pregnant women or lactating women or those planning to become pregnant within 18 months; 4. Patients who are unable to sense thirst and/or unable to drink water normally; 5. Patients with advanced diabetes, recent kidney surgery or acute kidney injury or other major kidney diseases; 6. Patients who participated in other clinical trials within 3 months; 7. Patients, as determined by the investigator, have other contraindications for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected volume growth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate (GFR) and serum creatinine (SCr);Echocardiography;Adverse events;Quality of life score; | — |
Countries
China
Contacts
Public ContactLi Zhou
China-Japan Friendship Hospital
Outcome results
None listed