Alport Syndrome
Conditions
Brief 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.
Interventions
DRUGRamipril
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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression time | Up to 240 weeks | a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease progression rate and eGFR slope | Up to 240 weeks | 5-year disease progression rate and eGFR slope |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | Up to 240 weeks | Number of patients with adverse events |
Countries
China
Contacts
Primary ContactGengru Jiang
Outcome results
None listed