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Hydroxychloroquine for Cardiovascular Disease in Chronic Kidney Disease (MaCK Trial)
MaCK Trial Summary
This trial is testing a new therapy for cardiovascular disease in patients with chronic kidney disease.
MaCK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMaCK Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MaCK Trial Design
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Who is running the clinical trial?
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- 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.I don't have a pacemaker, defibrillator, severe claustrophobia, or issues lying down.I cannot attend treatment or follow-up appointments.You have a history of a heart rhythm issue called prolonged QTc interval, or if you have a heart condition called bundle branch block and your adjusted QT interval is longer than 450.Your liver enzymes (AST and ALT) are more than 1.5 times the normal level, or your blood clotting test (INR) is higher than 1.4 without taking blood thinners.I have had sudden weight loss or changes in my vision without a known reason.I have had a heart attack, stroke, or heart failure in the last 3 months.I do not have chronic infections like HIV or Hepatitis.I have had cancer, a transplant, or a systemic inflammatory disease in the last year.I haven't been hospitalized for a serious infection or had a minor infection like a cold or skin infection in the last month.I have liver problems or cirrhosis.I haven't had dialysis or acute kidney injury in the last year.I have moderate to severe kidney disease with specific test results.I haven't taken steroids or immunosuppressants in the last 3 months.My doctor expects I have less than 12 months to live or I have had more than 2 hospital visits for heart failure in the last 6 months.I have a history of not following my treatment plans.I am between 18 and 80 years old.
- Group 1: Hydroxychloroquine (HCQ) Group
- Group 2: Placebo Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research project have an age limit?
"The age group that this study is looking for are individuals who have not yet hit their 80th birthday but are already 18 years old."
How many people are able to join this clinical trial?
"Yes, that is accurate. The listing on clinicaltrials.gov shows that this study was originally posted on December 14th, 2018 and was edited most recently on April 5th, 2022. They are looking for 100 patients from 1 location."
How is Hydroxychloroquine (HCQ) Group typically used?
"Hydroxychloroquine (HCQ) Group is the standard medication prescribed to patients suffering from lupus erythematosus, discoid. Additionally, Hydroxychloroquine (HCQ) Group can be used as an effective prophylactic against malaria, sarcoidosis, and q fever."
Are patients still being enrolled in this research project?
"Yes, this information is accurate. The study was first posted on December 14th, 2018 and is currently seeking patients for participation."
Who would this research project be most appropriate for?
"This trial is looking for 100 participants who are currently experiencing inflammation and meet the following criteria: 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 e"
What is the stance of the FDA on Hydroxychloroquine (HCQ)?
"Hydroxychloroquine (HCQ) Group was given a score of 2, meaning that while there is some evidence for its safety, there is no data yet supporting its efficacy."
Can you tell me what other research studies have been done on Hydroxychloroquine (HCQ)?
"There are currently 72 clinical trials underway for Hydroxychloroquine (HCQ) Group. Of these, 8 are in Phase 3 and the majority of them are based out of Hangzhou, Zhejiang. However, there are a total of 801 locations running trials for Hydroxychloroquine (HCQ) Group."
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