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Colchicine for Chronic Kidney Disease
Study Summary
This trial will study how well colchicine works in treating patients with chronic kidney disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 280 Patients • NCT01709981Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Placebo
- Group 2: Colchicine
- 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
What therapeutic use cases is Colchicine utilized for?
"Colchicine is the most accepted method for treating gout flares, as well as other medical conditions such as familial mediterranean fever, postcommissurotomy syndrome, and behcet's disorder."
What has been revealed about the potential health risks associated with Colchicine?
"Even though clinical evidence of Colchicine's efficacy is still pending, there have been studies demonstrating its safety. As such, we gave it a score of 2 out of 3 on our risk scale."
What is the upper limit of participants in this research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this research endeavour is actively seeking volunteers as of today. It was posted on November 1st 2021 and last amended on April 14th 2022; 20 participants are required for this trial which is based in one medical centre."
Does this research endeavor include the participation of elderly individuals?
"To participate in this medical study, patients must be between 21 and 80 years of age. As for younger or older people looking to join a trial, there are 61 studies aimed at minors and 645 that target seniors."
What types of participants are eligible for this medical experiment?
"This clinical trial is searching for 20 individuals of varying ages (21-80) suffering from chronic kidney disease. To meet the eligibility criteria, participants must have a glomerular filtration rate between 15 and 75 mL/min per 1.73 m2, an albumin-to-creatinine ratio greater than 200 mg/g, C-reactive protein concentration surpassing 2 mg/L within two weeks prior to screening, 25% or more reduction in high sensitivity C reactive protein during open label run in stage and left ventricular global longitudinal strain lower than -16% over the past year. Furthermore, those who require"
To what degree have other investigations explored the therapeutic potential of Colchicine?
"At present, 31 live clinical studies are being carried out for Colchicine and 12 of those are in Phase 3. The most populous city conducting research is New york City with 98 different sites actively working on trials relevant to this treatment."
Is enrollment for this experimental study currently available?
"Yes, according to the data available on clinicaltrials.gov this trial is actively seeking participants with an initial post date of November 1st 2021 and a most recent update from April 14th 2022. The study requires 20 patients at one site for enrollment."
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