Patients with end-stage kidney disease requiring hemodialysis who are currently on colchicine for gout prophylaxis. End-stage kidney disease, colchicine, pharmacokinetics
Conditions
Interventions
ESKD on HD with colchicine treatment for more than 3 months (Colchicine 0.6 mg PO weekly)
Treatment
Sponsors
Naresuan University, Faculty of Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age more than 20 years. 2. End-stage chronic kidney disease receiving hemodialysis 2 or 3 times per week. 3.Diagnosed gout with ongoing colchicine therapy for more than 3 months before enrollment. 4. Able to understand the study and provide voluntary, written informed consent.
Exclusion criteria
Exclusion criteria: 1. Concomitant use of strong cytochrome P450 CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, voriconazole, fluconazole) or strong P-glycoprotein inhibitors (e.g., clarithromycin, ritonavir). 2. History of allergy to colchicine. 3. History of severe cardiovascular disease affecting blood pressure. 4. Metastatic cancer. 5. End-stage liver disease (Child-Pugh class C). 6. Receiving peritoneal dialysis. 7. Pregnancy. 8. Declines to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ctrough of colchicine 3 peroids: 0 h pre-HD; Week 1 during HD at 0/1-2/4 h; Day 2-3 pre-HD Serum colchicine ng/mL by LC-MS measured at 0 h pre-HD, then 1 week later during HD at 0/1-2/4 h, then 2-3 days later 0 h pre-HD,Cmax of colchicine 3 peroids: 0 h pre-HD; Week 1 during HD at 0/1-2/4 h; Day 2-3 pre-HD Serum colchicine ng/mL by LC-MS measured at 0 h pre-HD, then 1 week later during HD at 0/1-2/4 h, then 2-3 days later 0 h pre-HD,AUC of colchicine 3 peroids: 0 h pre-HD; Week 1 during HD at 0/1-2/4 h; Day 2-3 pre-HD Serum colchicine ng/mL by LC-MS measured at 0 h pre-HD, then 1 week later during HD at 0/1-2/4 h, then 2-3 days later 0 h pre-HD | — |
Secondary
| Measure | Time frame |
|---|---|
| Colchicine toxicity 0 hour before HD Concentration at steady state of colchicine more than 3 ng/mL,Clinical toxicity 0 hour before HD myalgia, hyporeflexia,Laboratory toxicity 0 hour before HD CPK (rhabdomyolysis), LFTs (transaminitis), CBC (leukopenia) | — |
Countries
Thailand
Contacts
Public ContactTheerachai Thammathiwat
Naresuan University
Outcome results
None listed