Management of Cardiovascular Disease in Kidney Disease (MaCK) Study (NCT03636152) | Clinical Trial Compass
CompletedPhase 2
Management of Cardiovascular Disease in Kidney Disease (MaCK) Study
United States100 participantsStarted 2018-12-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Q…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.