Could an old malaria drug shield hearts in kidney disease?
NCT ID NCT03636152
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 Hide 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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