TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus

Status Completed

Clinical Trial Summary

This study is a 2-part study.

Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.

Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03002233
Study type	Interventional
Source	Toray Industries, Inc
Contact
Status	Completed
Phase	Phase 1
Start date	November 2016
Completion date	July 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04728984` - A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet	Phase 3
Completed	`NCT02143973` - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus	Phase 2/Phase 3
Terminated	`NCT01660243` - Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis	Phase 2
Completed	`NCT06159686` - The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus	Phase 1/Phase 2
Not yet recruiting	`NCT05525234` - A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus	Phase 4
Completed	`NCT03998163` - CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Phase 3
Active, not recruiting	`NCT05885737` - Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus	Phase 3
Recruiting	`NCT04393675` - Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients	Phase 1/Phase 2
Completed	`NCT03576235` - Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients	N/A
Completed	`NCT05575193` - Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis	N/A
Completed	`NCT02858726` - Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Phase 2/Phase 3
Completed	`NCT02143648` - Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus	Phase 2/Phase 3
Completed	`NCT00494975` - The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease	N/A
Recruiting	`NCT06446310` - Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus	Phase 3
Completed	`NCT03758079` - Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus	Phase 4
Completed	`NCT02229929` - Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus	Phase 2
Completed	`NCT04639674` - AST-120 in Hemodialysis Patients With Uremic Pruritus	Phase 4
Completed	`NCT03636269` - CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Phase 3
Not yet recruiting	`NCT06466421` - Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis	Phase 4
Completed	`NCT04711603` - A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.	Phase 3