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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05133050
Other study ID # XHEC-C-2021-070-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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Recruiting NCT04947813 - Genotype-Phenotype Correlations in Patients With Alport Syndrome