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NCT05133050 | Not yet recruiting | Alport Syndrome

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease

Alport Syndrome

Intervention/treatment

Ramipril

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 510 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026
Arm Intervention/treatment

Experimental: Experimental group

Drug: Ramipril The initial dose of ramipril is 2.5 mg /d. The blood pressure, blood potassium and blood creatinine is measured every 1-2 weeks. If the blood pressure is normal, the dose of ramipril is adjusted to 5 mg /d after 2 weeks. If the blood pressure is low, the dose of ramipril is reduced to 1.25 mg /d until the blood pressure becomes normal, otherwise, stop ramipril using. If the blood potassium is high (>5.5mmol/L), the dose of ramipril is reduced to 1.25 mg /d until the blood potassium becomes normal, otherwise, stop ramipril using. If the blood creatinine is higher before therapy (≥30%), the dose of ramipril is reduced to 1.25 mg /d until the blood creatinine becomes normal, otherwise, stop ramipril using.

No Intervention: Control group

No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.
Ages Eligible for Study: 30 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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;
  • Patients with microscopic hematuria and microalbuminuria: 30-300mg/24h or urine albumin/creatinine: 30-300mg/g;
  • No angiotensin converting enzyme inhibitor (ACEI) and other renin-angiotensin system inhibitors (including angiotensin II receptor antagonists, etc.) treatment.
Exclusion Criteria
  • 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;
  • Patients with bilateral renal artery stenosis or unilateral renal artery stenosis with solitary kidney;
  • Hyperkalemia, blood potassium>5.5mmol/L;
  • Severe aortic stenosis, severe mitral stenosis;
  • Treatment of drug allergy;
  • Hypertension or other diseases that may require treatment with angiotensin-converting enzyme inhibitors;
  • Disagree to participate in this research.
Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

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

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Locations

Not yet recruiting

China,

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China,