Comparative Analysis of Potential Toxicity from Long Term Colchicine Use in End-Stage Kidney Disease Underwent Hemodialysis versus Chronic Kidney Disease Stages 3-5: An Ambispective Non Inferiority Study Using Inverse Probability Weighted Confounder Summary Score

Comparative Analysis of Potential Toxicity from Long Term Colchicine Use in End-Stage Kidney Disease Underwent Hemodialysis versus Chronic Kidney Disease Stages 3-5, An Ambispective Non Inferiority Study Using Inverse Probability Weighted Confounder Summary Score

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20251021012

Enrollment

234

Registered

2025-10-21

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Patients with end-stage kidney disease requiring hemodialysis who are currently on colchicine for gout prophylaxis. 2. Patients with CKD G3-5 who are currently on colchicine for gout prophylaxis. End-stage kidney disease, colchicine, toxicity

Interventions

ESKD on HD with colchicine treatment for more than 3 months (Colchicine 0.6 mg PO weekly),CKD G3-5 with colchicine treatment for more than 3 months according to the current guideline dose recommendati

Treatment,Treatment

ESKD on HD,CKD G3-5

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 or CKD G3-5. 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
Colchicine toxicity at the time of inclusion of patient (3 months) % of patients with concentration at steady state of colchicine more than 3 ng/mL	—

Secondary

Measure	Time frame
Clinical toxicity at the time of inclusion of patient (3 months) % of patients with myalgia and/or hyporeflexia,Laboratory toxicity at the time of inclusion of patient (3 months) CPK (rhabdomyolysis), LFTs (transaminitis), CBC (leukopenia)	—

Countries

Thailand

Contacts

Public ContactTheerachai Thammathiwat

Naresuan University

theerachait@nu.ac.th055965105

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026