A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

Phase 1/2 Terminated 3 enrolled UCB Biopharma SRL

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).

Timeline

Start: 2019-10-21
Primary completion: 2022-05-04
Completion: 2022-05-04

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment challenges”

Publications

Zhou X, Trinh-Minh T, Matei AE, Gyorfi AH, Hong X, Bergmann C, Schett G, Atkinson J, Bowcutt R, Patel J, Johnson TS, Distler JHW. Amelioration of Fibrotic Remodeling of Human 3-Dimensional Full-Thickness Skin by Transglutamase 2 Inhibition. Arthritis Rheumatol. 2023 Sep;75(9):1619-1627. doi: 10.1002/art.42518. Epub 2023 Jul 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zampilimab	Unknown	—	—