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

Alport Syndrome Clinical Trial

Official title:

Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05133050
• Other study ID #: XHEC-C-2021-070-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Gengru Jiang
• Phone: +86-13917983703
• Email: jianggeng-ru[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 510
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alport Syndrome
• Nephritis, Hereditary
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with adverse events	Number of patients with adverse events	Up to 240 weeks
Primary	Disease progression time	a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria.	Up to 240 weeks
Secondary	5-year disease progression rate and eGFR slope	5-year disease progression rate and eGFR slope	Up to 240 weeks