Overview

Treatment With Metformin in Chinese Children With Alport Syndrome

Status:
Not yet recruiting
Trial end date:
2025-04-20
Target enrollment:
0
Participant gender:
All
Summary
This single-center, prospective, double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of metformin in Chinese children with Alport syndrome who have received (and continue to receive)) ACEi/ARB.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University First Hospital
Treatments:
Metformin
Criteria
Inclusion Criteria:

- (1) The diagnostic of Alport syndrome-hematuria with or without proteinuria meets one
or more of the following 4 items: i) Immunofluorescence staining of the α5 (IV) chain
of the glomerular basement membrane was abnormal; ii) electron microscopy of renal
biopsy showed diffuse changes in the glomerular basement membrane; iii) There was one
pathogenic variant in the COL4A5 gene or two pathogenic variants in the COL4A3/COL4A4
gene; iv) Family history of Alport syndrome.

(2) Age is older than or equal to 10 years old. (3) The 24-hour urine protein
quantification was greater than 150mg and the urine microalbumin-creatinine ratio was
greater than 30 mg/g.

(4) The estimated glomerular filtration rate (24-hour creatinine clearance) was
greater than 45 mL/min/1.73m2.

(5) Accept the maximum tolerated dose of renin-angiotensin-aldosterone system blockers
(Blood pressure in the clinic was in the 50th percentile of the same age, same sex and
same height but greater than 90/60mmHg, blood potassium was normal, and the increase
of blood creatinine did not exceed 30%) for at least 3 months.

Exclusion Criteria:

- (1) Vitamin B12 deficiency was uncorrected. (2) Treated with Furosemide, amiloride,
and nifedipine. (3) Hypertension, chronic liver disease, chronic heart disease, and
chronic kidney disease resulting from causes except Alport syndrome.

(4) History of hyperlactatemia. (5) Allergy to metformin. (6) kidney transplant. (7)
Poor compliance. (8) Type 1 diabetes.