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Anti-inflammatory
Colchicine for Chronic Kidney Disease
Phase 2
Recruiting
Led By Leo F Buckley, PharmD MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
eGFR of 15 to 75 mL/min per 1.73 m2
Age 21 years to 80 years
Must not have
Congenital heart disease (corrected or uncorrected)
Surgery within the previous 30 days or surgery planned to occur within the expected study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial will study how well colchicine works in treating patients with chronic kidney disease.
Who is the study for?
Adults aged 21-80 with chronic kidney disease, inflammation (high C-reactive protein levels), and heart strain are eligible. They must be able to consent, follow the study plan, have an eGFR of 15-75 mL/min/1.73 m2, and a high urine albumin level. Exclusions include colchicine allergy, recent hospitalization or surgery, severe heart failure or other serious conditions that increase risk.
What is being tested?
The trial is testing if colchicine can safely reduce inflammation in patients with chronic kidney disease compared to a placebo. Participants will either receive colchicine or a placebo pill without knowing which one they're getting to measure the true effect of the drug.
What are the potential side effects?
Colchicine may cause gastrointestinal issues like diarrhea and nausea, blood disorders such as low white cell counts leading to infection risks; muscle pain or weakness; and could interact negatively with certain other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by eGFR, is between 15 to 75 mL/min.
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I am between 21 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart condition I was born with.
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I have had surgery in the last 30 days or will have it during the study.
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My kidney function has worsened recently.
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I have had a heart transplant.
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I have been diagnosed with an autoimmune or auto-inflammatory condition like rheumatoid arthritis or lupus.
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My heart failure is severe, classified as stage C or D.
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My heart's pumping ability is below 40%.
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I have moderate to severe liver disease.
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I have had a heart attack or severe chest pain before.
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I have heart valve problems causing symptoms.
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I have not taken antibiotics or had an infection in the last 30 days.
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I have kidney failure and have had a transplant or need dialysis.
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I am currently taking medication that affects how drugs are processed in my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Between-group change in left ventricular global longitudinal strain
Secondary study objectives
Between-group change in left ventricular size
Between-group change in left ventricular systolic and diastolic function
Between-group change in left ventricular volumes
+1 moreSide effects data
From 2021 Phase 4 trial • 280 Patients • NCT017099811%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Colchicine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
Colchicine 0.3 mg once daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
2014
Completed Phase 4
~18130
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,604 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,311 Total Patients Enrolled
Leo F Buckley, PharmD MPHPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition I was born with.My doctor thinks I should take a medication for sugar control in my blood.You have a serious illness or condition that makes the doctor think participating in the study could be risky for you.Your heart function was very weak in the past year.I have had surgery in the last 30 days or will have it during the study.I haven't taken immunosuppressive or anti-inflammatory drugs in the last 30 days, except for a short treatment that has ended.My kidney function has worsened recently.My kidney function, measured by eGFR, is between 15 to 75 mL/min.I am taking the highest safe dose of specific heart or blood pressure medicine due to high protein in my urine.I have had a heart transplant.Your neutrophil count is less than 2000 cells/mm3.I have been diagnosed with an autoimmune or auto-inflammatory condition like rheumatoid arthritis or lupus.I have not been hospitalized in the last 30 days.My heart failure is severe, classified as stage C or D.I have not had cancer treatment in the last year.My doctor thinks my lung condition could make pneumonia worse.My heart's pumping ability is below 40%.You have had a bad reaction or are allergic to colchicine.Your blood platelet count is less than 50,000 cells/mm3.I have not had a gout flare or needed colchicine for other conditions in the past year.I am not on medications like simvastatin that could harm my muscles, and my muscle enzyme levels are normal.I have moderate to severe liver disease.Your C-reactive protein level didn't decrease by at least 25% during the initial phase of the study.Your blood test shows high levels of C-reactive protein.I have had a heart attack or severe chest pain before.I have heart valve problems causing symptoms.Your blood pressure is higher than 140 over 90.I have not taken antibiotics or had an infection in the last 30 days.I have kidney failure and have had a transplant or need dialysis.I am between 21 and 80 years old.You are currently breastfeeding.I am currently taking medication that affects how drugs are processed in my body.Your urine has a high level of albumin compared to creatinine.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Colchicine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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