About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: 30-50 Years;
Sex: All;
Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5; hematuria or microalbuminuria; eGFR>90 mL/min/1.73m2;
Patients with microscopic hematuria only;
Disqualifiers
With primary or secondary kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephropathy, benign renal arterioles, etc.;
Patients with a history of angioedema;
Hypovolemia or hypotension (systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 60mmHg);
Pregnant and lactating women;
Trial design
Parallel
Treatments tested in this trial
Ramipril
DrugWe 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.
Treatment groups
Trial outcomes
Primary outcomes
Disease progression time
a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria.
Secondary outcomes
5-year disease progression rate and eGFR slope
5-year disease progression rate and eGFR slope
Other outcomes
Number of patients with adverse events
Number of patients with adverse events
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: