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Management of Cardiovascular Disease in Kidney Disease (MaCK) Study

NCT03636152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

MRI carotid

To assess the carotid atherosclerotic plaques

PROCEDURE

APWV

Doppler measurement of the APWV

DRUG

Hydroxychloroquine

Active Drug

DRUG

Matching Placebo

Matching Placebo for the control group.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ashutosh M. Shukla, MD MBBS · North Florida/South Georgia Veterans Health System, Gainesville, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636152 on ClinicalTrials.gov