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NCT Number: NCT05133050

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

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.

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Key information

Conditions

Alport Syndrome Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Hereditary Skin and Connective Tissue Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril

Drug

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.

Primary outcomes

  1. Disease progression time

    Time frame: Up to 240 weeks

    a) Patients from no proteinuria to microalbuminuria; b) patients from microalbuminuria to dominant proteinuria.

Secondary outcomes

  1. 5-year disease progression rate and eGFR slope

    Time frame: Up to 240 weeks

    5-year disease progression rate and eGFR slope

Other outcomes

  1. Number of patients with adverse events

    Time frame: Up to 240 weeks

    Number of patients with adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Gengru Jiang

CONTACT

[email protected]

+86-13917983703

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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