Trial Outcomes & Findings for Management of Cardiovascular Disease in Kidney Disease (MaCK) Study (NCT NCT03636152)

NCT ID: NCT03636152

Last Updated: 2026-08-20

Results Overview

Measurements of Carotid TPV at enrollment and serially over 18th months

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

Baseline, 9 months, 18 months

Results posted on

2026-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Hydroxychloroquine (HCQ) Group These patients will receive HCQ 200mg, two tablets daily, for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group These patients will receive a matching placebo, two tablets daily, for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.
Overall Study STARTED	50	50
Overall Study COMPLETED	46	46
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management of Cardiovascular Disease in Kidney Disease (MaCK) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxychloroquine (HCQ) Group n=50 Participants These patients will receive HCQ for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group n=50 Participants These patients will receive a matching placebo for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.	Total n=100 Participants Total of all reporting groups
Age, Continuous	71.76 years STANDARD_DEVIATION 5.78 • n=5 Participants	69.9 years STANDARD_DEVIATION 6.03 • n=109 Participants	70.83 years STANDARD_DEVIATION 5.95 • n=133 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=109 Participants	5 Participants n=133 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	49 Participants n=109 Participants	95 Participants n=133 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=109 Participants	1 Participants n=133 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=109 Participants	18 Participants n=133 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	41 Participants n=109 Participants	81 Participants n=133 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=109 Participants	100 participants n=133 Participants

PRIMARY outcome

Timeframe: Baseline, 9 months, 18 months

Measurements of Carotid TPV at enrollment and serially over 18th months

Outcome measures

Outcome measures
Measure	Hydroxychloroquine (HCQ) Group n=50 Participants These patients will receive HCQ for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group n=50 Participants These patients will receive a matching placebo for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.
Total Plaque Volume (TPV), Carotid Baseline	1498.57 mm3 Standard Deviation 341.54	1674.38 mm3 Standard Deviation 439.89
Total Plaque Volume (TPV), Carotid 9 Months	1379.49 mm3 Standard Deviation 241.06	1587.73 mm3 Standard Deviation 397.99
Total Plaque Volume (TPV), Carotid 18 Months	1526.28 mm3 Standard Deviation 286.02	1677.78 mm3 Standard Deviation 401.40

SECONDARY outcome

Timeframe: Baseline, 9 months, 18 months

Population: results include for those the laboratory data is available and does not include missing data

Measurements of hsCRP at enrollment and serially over 18 months

Outcome measures

Outcome measures
Measure	Hydroxychloroquine (HCQ) Group n=50 Participants These patients will receive HCQ for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group n=50 Participants These patients will receive a matching placebo for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.
High Sensitivity C-Reactive Protein (hsCRP) 9-month	4.59 Milligrams per liter Standard Deviation 9.67	5.65 Milligrams per liter Standard Deviation 7.14
High Sensitivity C-Reactive Protein (hsCRP) Baseline	4.23 Milligrams per liter Standard Deviation 8.12	3.44 Milligrams per liter Standard Deviation 2.88
High Sensitivity C-Reactive Protein (hsCRP) 18-month	4.15 Milligrams per liter Standard Deviation 5.91	4.48 Milligrams per liter Standard Deviation 4.87

SECONDARY outcome

Timeframe: Baseline, 9 months, 18 months

Population: Data provided for those available; missingness in the primary reporting.

Measurements of APWV at enrollment and serially over 18 months

Outcome measures

Outcome measures
Measure	Hydroxychloroquine (HCQ) Group n=50 Participants These patients will receive HCQ for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group n=50 Participants These patients will receive a matching placebo for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.
Aortic Pulse Wave Velocity (APWV) 18-month	9.21 meter/second Standard Deviation 1.99	9.64 meter/second Standard Deviation 1.91
Aortic Pulse Wave Velocity (APWV) Baseline	9.43 meter/second Standard Deviation 1.91	9.65 meter/second Standard Deviation 1.96
Aortic Pulse Wave Velocity (APWV) 9-month	8.86 meter/second Standard Deviation 1.95	8.95 meter/second Standard Deviation 1.97

Adverse Events

Hydroxychloroquine (HCQ) Group

Serious events: 26 serious events

Other events: 21 other events

Deaths: 3 deaths

Placebo Group

Serious events: 20 serious events

Other events: 11 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Ashutosh M. Shukla, MD

North Florida South Georgia Veteran Healthcare System

Phone: 352-548-6813

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Hydroxychloroquine (HCQ) Group n=50 participants at risk These patients will receive HCQ for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Hydroxychloroquine: Active Drug	Placebo Group n=50 participants at risk These patients will receive a matching placebo for 18 months MRI carotid: To assess the carotid atherosclerotic plaques APWV: Doppler measurement of the APWV Matching Placebo: Matching Placebo for the control group.
Cardiac disorders Heart Failure	12.0% 6/50 • Number of events 16 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Cardiac disorders Arrhythmias	18.0% 9/50 • Number of events 9 • through the duration of study, with each participant followed for a scheduled 18 months	10.0% 5/50 • Number of events 5 • through the duration of study, with each participant followed for a scheduled 18 months
Cardiac disorders Coronary Events	8.0% 4/50 • Number of events 5 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Cardiac disorders Others	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months	4.0% 2/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months
Renal and urinary disorders CKD progression	8.0% 4/50 • Number of events 4 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Renal and urinary disorders AKI	14.0% 7/50 • Number of events 7 • through the duration of study, with each participant followed for a scheduled 18 months	8.0% 4/50 • Number of events 4 • through the duration of study, with each participant followed for a scheduled 18 months
Renal and urinary disorders Hypercalcemia	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Renal and urinary disorders Urology	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Blood and lymphatic system disorders RBC disorders	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Blood and lymphatic system disorders WBC disorders	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Blood and lymphatic system disorders Bleeding diathesis	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Nervous system disorders Cebrovasclar disorders	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Nervous system disorders others	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Psychiatric disorders Misc	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Respiratory, thoracic and mediastinal disorders Hypoxic disorders	4.0% 2/50 • Number of events 2 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Respiratory, thoracic and mediastinal disorders Infections	4.0% 2/50 • Number of events 2 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Infections and infestations systemic infections	8.0% 4/50 • Number of events 4 • through the duration of study, with each participant followed for a scheduled 18 months	8.0% 4/50 • Number of events 5 • through the duration of study, with each participant followed for a scheduled 18 months
Infections and infestations COVID-19 and Vaccine-related	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Gastrointestinal disorders Gastritis or Bleed	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months
Gastrointestinal disorders Motility disorders	10.0% 5/50 • Number of events 5 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 2 • through the duration of study, with each participant followed for a scheduled 18 months
Eye disorders Photosensitivity	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Eye disorders presbyopia	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months
Endocrine disorders Glucose fluctuations	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Endocrine disorders pancreatitis	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Skin and subcutaneous tissue disorders dermatitis	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months	2.0% 1/50 • Number of events 1 • through the duration of study, with each participant followed for a scheduled 18 months
Musculoskeletal and connective tissue disorders back pain	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months	4.0% 2/50 • Number of events 2 • through the duration of study, with each participant followed for a scheduled 18 months
Musculoskeletal and connective tissue disorders others	0.00% 0/50 • through the duration of study, with each participant followed for a scheduled 18 months	6.0% 3/50 • Number of events 3 • through the duration of study, with each participant followed for a scheduled 18 months
General disorders Miscellenous	12.0% 6/50 • Number of events 6 • through the duration of study, with each participant followed for a scheduled 18 months	4.0% 2/50 • Number of events 2 • through the duration of study, with each participant followed for a scheduled 18 months