Could an old malaria drug shield hearts in kidney disease?

NCT ID NCT03636152

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether hydroxychloroquine, an anti-inflammatory drug, can reduce cardiovascular disease risk in people with chronic kidney disease (CKD). Participants with moderate-to-severe CKD will receive either hydroxychloroquine or a placebo for 18 months. Researchers will measure changes in carotid artery plaque, blood vessel stiffness, and inflammation to see if the drug offers heart protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydroxychloroquine (an anti-inflammatory drug) compared with placebo
What this could lead to
If it works, this could open a new treatment avenue to lower heart disease risk in people with chronic kidney disease.
What could go wrong
This is an early proof-of-concept trial, so results may not hold up in larger studies. Hydroxychloroquine can have side effects, and the benefit is unproven.

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

100 people

The number who actually took part.

Started

Dec 2018

Finished

Jan 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 80 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: * Veteran * Age 18-80 years; * Moderate to severe CKD at the time of screening, defined as one of the following: 1) Stage 3b or 4 CKD with latest eGFR of 25-59, with diabetes mellitus, OR 2) Stage 3b or 4 CKD with latest eGFR of 25 to 45 mL/min and maximum recorded albuminuria defined as urine albumin/creatinine ratio (UACR) of 30 mg/g, OR 3) Stage 3a CKD with eGFR 46-59 ml/min with urine albumin/creatinine (UACR) 100 mg/gm Exclusion Criteria: * G6PD deficiency or known hypersensitivity to 4-aminoquinoline * Conventional contraindications for non-contrast MRI examination including * Permanent pacemaker * Automatic Implantable Cardioverter Defibrillator * Significant fear of closed space * Claustrophobia that prevents patients from participating * Inability to lie down * Abnormal liver functions or diagnosis of cirrhosis * AST and ALT more than 1.5 times the normal or INR without being anti-coagulated greater than 1.4 * History of documented non-adherence to therapy * Inability to attend treatment or follow-up scheduling * Less than 6 months since initiation of 'Statins' * Prior history of any dialysis within last 12 months, or history of diagnosed AKI in the prior three months * History of acute cardiovascular event defined as: * myocardial infarction * stroke or new diagnosis of congestive heart failure or heart failure related admission in prior 3 months * History of prolonged QTc interval 450, For patients with BBB an adjusted QT interval \>450 * Known chronic active infections like HIV, Hepatitis B or Hepatitis C positive, chronic osteomyelitis etc. * Recent serious infection including requiring hospitalization within 3 months or Recent minor infection such as skin, soft tissue or respiratory infections within 30 days of enrollment * Active or recently treated (\< 1 year in remission) malignancy, transplantation, or systemic inflammatory diseases * Patients with localized squamous cell carcinoma of the skin are eligible * Use of systemic corticosteroids or other immunosuppression within last 3 months (acute course of steroid for a gouty arthritis or chronic obstructive pulmonary disease is eligible if \> 1 month ago) * Pregnancy, breastfeeding or planning to become pregnant during the course of the study * Life expectancy less than 12 months or uncontrolled congestive heart failure (CHF) * defined as more than 2 admissions in prior 6 months) * Any other condition the PI determines may put the research subject in jeopardy during the course of the study * Recent unexplained weight loss or vision changes

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

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