Management of Cardiovascular Disease in Kidney Disease (MaCK) Study

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Chloroquine; Hydroxychloroquine

Criteria

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