Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Colchicine with Standard treatment: In this study, the intervention drug is low dose colchicine administered orally at a dosage of zero point five milligrams once daily. The drug will b
Sponsors
Academic
Eligibility
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in the study must be adults aged eighteen years or older who meet specific clinical and laboratory criteria. They must have chronic kidney disease defined by either of the following: an estimated glomerular filtration rate between thirty and ninety milliliters per minute per one point seven three square meters, calculated using the CKD EPI creatinine equation, with stable renal function defined as a decline in eGFR of less than fifteen milliliters per minute over the past three months; or a urine albumin to creatinine ratio greater than two hundred milligrams per gram, with eGFR also between thirty and ninety milliliters per minute per one point seven three square meters and stable renal function. Additionally, participants must have a high sensitivity C reactive protein level greater than two milligrams per liter, indicating systemic inflammation. They must also have established atherosclerotic cardiovascular disease, evidenced by at least one of the following: coronary heart disease such as a documented history of myocardial infarction, prior coronary revascularization, or fifty percent or more stenosis in a major epicardial coronary artery confirmed by cardiac catheterization or CT coronary angiography; cerebrovascular disease including a prior atherosclerotic stroke, prior carotid revascularization, or fifty percent or more stenosis in a carotid artery demonstrated by angiography or Doppler studies; or symptomatic peripheral artery disease such as intermittent claudication with an ankle brachial index of zero point nine or less, fifty percent or more stenosis in peripheral arteries excluding carotid, prior peripheral revascularization, or lower extremity amputation due to atherosclerotic disease. Laboratory results for eGFR, spot protein creatinine ratio, and high sensitivity C reactive protein used to determine eligibility may be based on measurements taken within ninety days prior to screening or obtained during the screening visit.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they have any of the following conditions or circumstances. Those with severe heart failure classified as grade four by the New York Heart Association or with a left ventricular ejection fraction less than thirty five percent will not be eligible. Individuals who have undergone coronary artery bypass surgery within the previous three years or have a planned bypass procedure will also be excluded. Patients with inflammatory bowel disease or chronic diarrhea, neuromuscular diseases, or persistently elevated creatine kinase levels greater than three times the upper limit of normal not attributable to infarction will not be included. Participants with clinically significant nontransient hematologic abnormalities or with severe renal failure defined as a persistent estimated glomerular filtration rate below thirty milliliters per minute per one point seven three square meters will be excluded. Those with severe liver disease, a history of recreational drug or alcohol abuse, or ongoing or planned long term systemic glucocorticoid therapy initiated within three months prior to the study are not eligible. A history of clinically significant sensitivity or allergy to colchicine will lead to exclusion. Participants with clinical evidence or suspicion of active infection at the discretion of the investigator will be excluded. Those who experienced a myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within sixty days prior to randomization will not be eligible. Any planned coronary, carotid, or peripheral artery revascularization known at the time of randomization will also be grounds for exclusion. Lastly, individuals who have undergone major cardiac or noncardiac surgical procedures, including major endoscopic procedures such as thoracoscopic or laparoscopic surgery, within the past sixty days, or those with any major surgical procedure planned at the time of randomization, will be excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the effect of low dose colchicine along with standard therapy in reducing the risk of MACE (Composite of cardiovascular death, spontaneous MI, ischemic stroke, ischemia-driven coronary revascularization) in participants with established atherosclerotic cardiovascular disease, Chronic kidney disease and systemic inflammationTimepoint: MACE events will be calculated at end of 1 year and 3 years of study initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of low dose colchicine in reducing the risk of expanded MACE such as the combination of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke; the combination of spontaneous myocardial infarction or ischemia driven coronary revascularization; the combination of cardiovascular death or spontaneous myocardial infarction; ischemia driven coronary revascularization alone; spontaneous myocardial infarction alone; ischemic stroke alone; death from any cause; & cardiovascular death specifically.Timepoint: Expanded MACE events will be assessed at one & three years of study initiation;To assess the reduction in risk of hospitalization for heart failureTimepoint: three years of initiation of the study;To assess for all cause mortalityTimepoint: Three years of initiation of the study;To assess the change in inflammatory markers Hs-CRP & Interleukin 6 at baseline, 6 months & 1 year of randomisationTimepoint: at start of the study & at six months & one year of randomisation;To assess the role of colchicine in delaying progression of CKDTimepoint: at initiation of the study & six monthly until end of the study | — |
Countries
India
Contacts
Public ContactSREE BHUSHAN
Nizams Institute of Medical sciences
Outcome results
None listed