Treatment With Metformin in Chinese Children With Alport Syndrome

Sponsor
Peking University First Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05655728
Collaborator
(none)
78
2
27.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Metformin in Alport Syndrome: A Randomized, Double-blind, Placebo-controlled Study in China
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jan 31, 2025
Anticipated Study Completion Date :
Apr 20, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Metformin intervention treatment group

Drug: Metformin
The participants will receive treatment of metformin (initial dose of 500 mg/day, within 2 weeks reaching the maximum tolerated dose [maximum: 1500 mg/day]).

Placebo Comparator: The placebo treatment group

Other: Placebo
The participants will receive treatment of placebo.

Outcome Measures

Primary Outcome Measures

  1. Efficacy of metformin for Alport syndrome [24 months]

    either decrease in proteinuria or steady eGFR from baseline. To assess the decrease in proteinuria or steady eGFR from baseline to month 12 or month 24 under metformin treatment compared to placebo

  2. Safety of metformin for Alport syndrome [24 months]

    The occurrence of adverse events. Safety will be assessed by monitoring adverse drug events, physical examinations and clinical laboratory test through 24 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University First Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie DING, Professor, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT05655728
Other Study ID Numbers:
  • MCCAS
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022