Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    50
  • sponsor
    Shanghai Children's Hospital
Updated on 24 September 2021

Summary

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

Description

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

Patients in the Phase 2 cohort will be randomized 1:1 to either Hydroxychloroquine Cohort or Comparator Cohort.

All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 4, 12, and 24. Patients will not receive study drug during a 24-week withdrawal period between Weeks 25 and 48. Patients will also be scheduled to be assessed at an in person follow up visit at Week 36, and 48.

Details
Condition Alport's Syndrome
Treatment Hydroxychloroquine Sulfate 100 milligram (mg) Tab, Benazepril hydrochloride 10 milligram (mg) Tab
Clinical Study IdentifierNCT04937907
SponsorShanghai Children's Hospital
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female
Age 3-18 years old
Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome, including COL4A3, COL4A4, or COL4A5) or histologic assessment using electron microscopy
Screening eGFR 90 mL/min/1.73 m2
ACE inhibitor and/or ARB, the dosing regimen should be stable for at least 4 weeks prior to screening
No antirheumatic drugs such as hydroxychloroquine have been used
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

Causes of chronic kidney disease aside from Alport syndrome (including but not limited to other heritable disorders leading to chronic kidney disease, diabetic nephropathy, hypertensive nephropathy, lupus nephritis, IgA nephropathy)
Prior exposure to hydroxychloroquine
Ongoing chronic hemodialysis or peritoneal dialysis therapy
Renal transplant recipient
Any clinically significant illness within 4 weeks before screening or surgical or medical condition (other than Alport syndrome) that could interfere with the subject's study compliance; confound the study results; impact subject safety; or significantly alter the absorption, distribution, metabolism, or excretion of drugs
Participation in other interventional clinical studies
Known hypersensitivity to any component of the study drug
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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