Hydroxychloroquine for Cardiovascular Disease in Chronic Kidney Disease

(MaCK Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ashutosh M. Shukla, MD MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Cardiovascular disease (CVD) is the largest concerns for patients with Chronic kidney disease (CKD). At present time the investigators do not have proven effective strategies to reduce high CVD related deaths in CKD. This study assesses a novel therapy (hydroxychloroquine, HCQ) for the treatment of CVD in patients with CKD. This is the first human proof-of-concept study and is planned to be conducted among US Veterans, who suffer from both CKD and CVD at a disproportionately greater rates. The outcome of this study has the potential to provide an entirely new line of therapy for the treatment of CVD in CKD.

Eligibility Criteria

This trial is for US Veterans aged 18-80 with moderate to severe chronic kidney disease (CKD), who may also have diabetes or high levels of protein in their urine. It's not for those with recent serious infections, heart events, certain chronic diseases like HIV or Hepatitis B/C, pregnant women, or anyone with conditions that could jeopardize their safety as determined by the principal investigator.

Inclusion Criteria

Veteran

I have moderate to severe kidney disease with specific test results.

I am between 18 and 80 years old.

Exclusion Criteria

I am allergic to 4-aminoquinoline or have G6PD deficiency.

I have a type of skin cancer called squamous cell carcinoma that has not spread.

I started taking statins less than 6 months ago.

Treatment Details

Interventions

• Hydroxychloroquine (Antimalarial)

Trial Overview The MaCK Study tests hydroxychloroquine (HCQ) as a new treatment option for cardiovascular disease in patients with CKD. Participants will either receive HCQ or a placebo and undergo MRI scans to measure the effects on heart and blood vessel health.

Participant Groups

Group I: Hydroxychloroquine (HCQ) Group Active Control 3 Interventions

These patients will receive HCQ for 18 months

Group II: Placebo Group Placebo Group 3 Interventions

These patients will receive a matching placebo for 18 months

Hydroxychloroquine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Plaquenil for:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

🇪🇺 Approved in European Union as Plaquenil for:

• Malaria
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

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

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References