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Randomized controlled trial of endothelin receptor antagonists for Alport syndrome

Randomized controlled trial of endothelin receptor antagonists for Alport syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107030
Enrollment
Unknown
Registered
2025-08-01
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Alport syndrome

Interventions

ERA group:The experimental group received ambrisentan 5 mg qd (from Day 0 to Month 6).
Placebo group:The placebo group received placebo 5 mg qd (from Day 0 to Month 6).

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old=0.5g/d; 5. eGFR>25ml/min/1.73m^2 (calculated by CKD-EPI formula); 6. Chest CT images within half a year did not show pulmonary fibrosis; 7. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Received immunosuppressive therapy (hormones, cyclosporine, hydroxychloroquine, tacrolimus, mycophenolate mofetil, tripterygium vine) in the past 3 months; 2. Combined with other glomerular diseases; 3. Those with a history of idiopathic pulmonary fibrosis; 4. Hypotension (SBP twice the upper limit of normal); 6. History of malignant tumors, organ transplantation or chronic liver disease; 7. Dialysis patients; 8. Those who have allergic reactions or angioedema to Amrisentan; 9. Life expectancy less than 1 year; 10. Patients during pregnancy and lactation; 11. Female patients who are preparing for pregnancy during the study; 12. Participated in other drug clinical studies in 1 month before screening; 13. Those who have lost the ability to act independently; 14. The investigator believes that it is not suitable to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
24hUTP;

Secondary

MeasureTime frame
eGFR;UACR;

Countries

China

Contacts

Public ContactXujie Zhou

Peking University First Hospital

zhouxujie@bjmu.edu.cn+86 182 0105 7217

Outcome results

None listed

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