Skip to content

A multicenter, randomized, double-blind, crossover controlled clinical study of the treatment of Alport syndrome with Henagliflozin, Finerenone, and combination therapy.

A multicenter, randomized, double-blind, crossover controlled clinical study of the treatment of Alport syndrome with Henagliflozin, Finerenone, and combination therapy.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079455
Enrollment
Unknown
Registered
2024-01-03
Start date
2024-01-03
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport syndrome

Interventions

SGLT2i group:Henagliflozin: In the first cycle (from day 1 to day 60), patients assigned to the SGLT2i group were required to take the corresponding medication for one month (SGLT2i group: Henaglifloz
MRA group:Finerenone: The first cycle (from day 1 to day 60) involved patients randomly assigned to the MRA group who were required to take the corresponding medication for one month (MRA group: Finer
SGLT2i+MRA group:Henagliflozin+Finerenone: The first cycle (Day 1 to Day 60) involved the random allocation of patients to the combination therapy group, where they were required to take the correspon

Sponsors

peking university first hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age = 14 years old; 2. The patient or their first-degree relative has been diagnosed with Alport syndrome through renal biopsy; 3. Diagnosis of Alport syndrome through genetic testing, regardless of inheritance pattern; 4. Received stable doses of RAAS inhibitors within the 3 months prior to randomization; 5. eGFR > 40ml/min/1.73m2 (calculated by CKD-EPI formula); 6. Proteinuria has been detected in two consecutive tests (with at least a 2-week interval), and the 24-hour urine protein quantification (24hUTP) in two consecutive tests is >0.8g/d; 7. Willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Merge other glomerular diseases; 2. Received immunosuppressive therapy (such as steroids, cyclosporine, hydroxychloroquine, tacrolimus, mycophenolate mofetil, and leflunomide) within the past 3 months, except for the following cases: a dose of =0.5 mg/kg prednisolone for non-renal indications (such as allergies or asthma) with continuous use of no more than 2 weeks; 3. History of diabetes; 4. Body mass index (BMI) 180mmHg); 8. Hypotension (SBP3 times the upper limit of normal); 10. History of malignant tumors, organ transplantation, or chronic liver disease; 11. Expected life span of less than 1 year; 12. Pregnant or lactating patients; 13. Female patients planning to become pregnant during the study period; 14. Patients receiving itraconazole, lopinavir-containing preparations, azanavir, darunavir, fosamprenavir-containing preparations, cobicistat-containing preparations, or clarithromycin; 15. Hyperkalemia (serum potassium >5.5mmol/L); 16. Patients with Addison's disease; 17. Participated in other drug clinical trials in the month prior to screening; 18. Patients who have lost the ability to act independently; 19. The investigator deems it inappropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
24hUTP;

Secondary

MeasureTime frame
eGFR;UACR;

Countries

China

Contacts

Public ContactXujie Zhou

Renal Department, Peking University First Hospital

liyang_3337@163.com+86 185 1964 0755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026