Kidney Week

Abstract: TH-PO0818

Comparative Analysis of Potential Toxicity from Long-Term Colchicine Use in Patients with ESKD on Hemodialysis vs. CKD G3-G5: An Ambispective Noninferiority Study Using Inverse Probability Weighting (IPW) Confounder Summary Score

Session Information

• Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

• 1900 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Authors

• Thammathiwat, Theerachai, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Theerachai Thammathiwat, MD, MSc

• Pichitsiri, Watchara, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Watchara Pichitsiri

• Kongtal, Noppakloa, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Noppakloa Kongtal, MD

• Patumanond, Jayanton, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Jayanton Patumanond

• Tangchitthavorngul, Suri, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Suri Tangchitthavorngul, MD, MSc

• Wannakittirat, Anyarin, Naresuan University Faculty of Medicine, Phitsanulok, Thailand

Anyarin Wannakittirat, MD

• Udomkarnjananun, Suwasin, Chulalongkorn University Faculty of Medicine, Bangkok, Thailand

Suwasin Udomkarnjananun, MD

Background

Although colchicine dose adjustment is recommended in CKD, use in ESKD receiving hemodialysis (HD) remains restricted because of limited pharmacokinetic safety data. We evaluated whether ESKD on HD was non-inferior to CKD in potential colchicine toxicity during long-term therapy.

Methods

We conducted an ambispective comparative study of CKD and ESKD patients, all receiving long-term colchicine. CKD sampling consisted mainly of pre-dose and 2-hour post-dose concentrations, whereas ESKD sampling was performed before, during, and immediately after HD. The primary endpoint was maximum observed blood colchicine concentration ≥3 ng/mL, with ≥5 ng/mL as a secondary threshold. A confounder summary score for ESKD status was estimated using age, sex, body weight, and CYP3A4/P-glycoprotein interacting medication use, and IPW was then applied for exploratory adjustment. Figure 1 shows cohort and pseudocohort distributions and the SMD plot for covariate balance assessment. Non-inferiority was assessed using a 10% absolute risk difference margin.

Results

A total of 239 patients were included: 216 CKD and 23 ESKD on HD. For the maximum observed concentration endpoint, 237 patients had evaluable data. Concentration ≥3 ng/mL occurred in 64/214 CKD patients (29.9%) and 9/23 ESKD patients (39.1%). Concentration ≥5 ng/mL occurred in 12/214 CKD patients (5.6%) and 2/23 ESKD patients (8.7%). Trough-like concentration ≥3 ng/mL was uncommon, occurring in 1 CKD patient (0.46%) and 1 ESKD patient (4.35%); no patient had trough-like concentration ≥5 ng/mL. After weighting, the adjusted risk difference for ≥3 ng/mL was 4.5% (95% CI, −25.5% to 34.5%; p=0.768), which did not meet the non-inferiority margin. For ≥5 ng/mL, the adjusted risk difference was −3.9% (95% CI, −9.1% to 1.3%; p=0.144), meeting the non-inferiority criterion.

Conclusion

ESKD on HD did not show significantly higher potential colchicine toxicity than CKD. Non-inferiority was not established at ≥3 ng/mL but was supported at ≥5 ng/mL. Long-term very-low-dose colchicine may be possible in selected HD patients with careful monitoring.

Funding

• Government Support – Non-U.S.