Adult patients with chronic kidney disease stage 3 and 4, defined by KDIGO criteria which eGFR by creatinine-based Thai GFR equation is 15-59ml/min/1.73 m2 of BSA. colchicine, renal fibrosis, urine transforming growth factor beta 1, urine monocyte chemotactic protein1
Conditions
Interventions
0.6 mg colchicine one tab orally on alternate day,placebo one tab orally on alternate day
Active Comparator Drug,Placebo Comparator Drug
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients, age between 18 to 85 years old 2. Chronic kidney disease stage 3 and 4, defined by KDIGO criteria which eGFR by creatinine-based Thai GFR equation is 15-59 ml per minute per 1.73 m2 of body surface area.
Exclusion criteria
Exclusion criteria: 1) acute kidney injury within 1 month before randomization 2) colchicine exposure within 3 month before randomization 3) kidney transplant patients 4) pre-existing or plan for immunosuppressive therapy 5) woman with pregnancy, lactation or unwilling to take contraception methods 6) cirrhosis or active hepatitis defined by elevated serum AST and/or ALT twice the upper limit 7) chronic diarrhea 8) neuromuscular disease 9) hematologic disease or abnormal complete blood count, any of the following; hemoglobin < 10 g/dL, white blood count <3,000 x 109/L or Platelet <100,000 x 109/L 10) active malignancy 11) pre-existing use of strong CYP3A4 or P-glycoprotein inhibitors medication 12) colchicine allergy 13) active COVID-19 infection before 2 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in urine transforming growth factor beta-1 level from baseline to 12 weeks 12 weeks ELISA method | — |
Secondary
| Measure | Time frame |
|---|---|
| change in urine monocyte chemotactic protein-1, urine albumin creatinine ratio, 24-hour urine protein, serum creatinine, CRP, WBC, neutrophil-to-lymphocyte ratio 2) safety outcomes 12 weeks ELISA, standard laboratory method | — |
Countries
Thailand
Contacts
Public ContactThunyatorn Wuttiputhanun
Chulalongkorn University and King Chulalongkorn Memorial Hospital
Outcome results
None listed