Effects of colchicine on renal fibrosis marker in patients with chronic kidney disease
- Conditions
- 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
- Registration Number
- TCTR20220214005
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change in urine transforming growth factor beta-1 level from baseline to 12 weeks 12 weeks ELISA method
- Secondary Outcome Measures
Name Time Method 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