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Could a malaria drug help kids with a rare kidney disease?

NCT ID NCT04937907

Disease control Sponsor: Shanghai Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether hydroxychloroquine, a drug used for malaria and autoimmune conditions, can safely reduce blood and protein in the urine of children with X-linked Alport syndrome, a genetic kidney disease. Fifty children aged 3 to 18 with stable kidney function took the drug for 48 weeks. The goal was to see if it could help control kidney damage, not cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alport syndrome hereditary nephritis X-linked Alport syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alport syndrome, X-linked

Contacts and locations

Locations

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, 200062, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.