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Clinical Trials in China / NCT05133050
Starting soon Not applicable

Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

NCT05133050 · tracked via the Priya Life Science China tracker
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2022-01-01
Last updated
2021-11-24

Condition(s) studied

Alport Syndrome

Investigational drug(s) / intervention(s)

Ramipril

Ramipril: We use ACEI: ramipril, in this prospective, randomized, controlled and multicenter clinical trial to access the safety and efficacy in Alport syndrome patients carried COL4A3/COL4A4/COL4A5 variants.

Study summary

Alport syndrome (AS) is the second most common monogenic cause of end-stage renal failure (ESRF). AS is caused by variants in the COL4A3, COL4A4, and COL4A5 genes, which encode for the a3, a4, and a5 chains of type IV collagen. This trial is a prospective, randomized, controlled and multicenter trial. Mainly to assess the safety and efficacy of ramipril in Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5.

Eligibility

Sex
ALL
Min age
30 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age: 30-50 Years; 2. Sex: All; 3. Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5; hematuria or microalbuminuria; eGFR\>90 mL/min/1.73m2; 4. Patients with microscopic hematuria only; 5. Patients with microscopic hematuria and microalbuminuria: 30-300mg/24h or urine albumin/creatinine: 30-300mg/g; 6. No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment. Exclusion Criteria: 1. With primary or secondary kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephropathy, benign renal arterioles, etc.; 2. Patients with a history of angioedema; 3. Hypovolemia or hypotension (systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 60mmHg); 4. Pregnant and lactating women; 5. Patients with bilateral renal artery stenosis or unilateral renal artery stenosis with solitary kidney; 6. Hyperkalemia, blood potassium\>5.5mmol/L; 7. Severe aortic stenosis, severe mitral stenosis; 8. Treatment of drug allergy; 9. Hypertension or other diseases that may require treatment with angiotensin-converting enzyme inhibitors; 10. Disagree to participate in this research.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China

On this site

📄 Altace (ramipril) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05133050 on ClinicalTrials.gov ↗ ← All trials in China