NCT05135390 is a Phase 3 clinical trial of HSK21542 in Pruritus, sponsored by Haisco Pharmaceutical Group Co., Ltd..

Who is sponsoring NCT05135390?

NCT05135390 is sponsored by Haisco Pharmaceutical Group Co., Ltd..

What drugs are being tested in NCT05135390?

Interventions in NCT05135390: HSK21542, Placebo.

What condition does NCT05135390 study?

NCT05135390 studies Pruritus, Hemodialysis Patients with Moderate-to-Severe Pruritus.

Is NCT05135390 still recruiting?

NCT05135390 is currently completed. Last updated 31 December 2024.

Last reviewed 2024-12-31 · How we verify

NCT05135390

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients with Chronic Kidney Disease-Associated Pruritus

Completed Phase 3 Last updated 31 December 2024

What this trial tests

Phase 3 trial testing HSK21542 in Pruritus in 545 participants. Completed in 6 June 2024.

Timeline

17 June 2022

Primary endpoint
27 July 2023

6 June 2024

Quick facts

Lead sponsor	Haisco Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	545
Start date	17 June 2022
Primary completion	27 July 2023
Estimated completion	6 June 2024
Sites	2 locations across China

Drugs / interventions tested

HSK21542
Placebo

Conditions studied

Pruritus — all drugs for Pruritus →
Hemodialysis Patients with Moderate-to-Severe Pruritus — all drugs for Hemodialysis Patients with Moderate-to-Severe Pruritus →

Sponsor

Haisco Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Pruritus or Hemodialysis Patients with Moderate-to-Severe Pruritus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center, randomized, double-blind, placebo-controlled study. About 544 maintenance hemodialysis patients with moderate or above chronic kidney disease-associated pruritus are planned to be enrolled. They will randomized into the treatment group (HSK21542, 0.3 μg/kg) and the control group (placebo) at a 1:1 ratio.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Kappa opioid agonists in the treatment of itch: just scratching the surface?
Beck TC, Wilson EM, Wilkes E, Lee LW, et al · · 2023 · cited 8× · PMID 38099236 · DOI 10.1097/itx.0000000000000072
Efficacy and safety of anrikefon in patients with pruritus undergoing haemodialysis: multicentre, double blind, randomised placebo controlled phase 3 trial.
Liu BC, Li ZL, Zhang P, Zhong AM, et al · · 2025 · cited 3× · PMID 40829896 · DOI 10.1136/bmj-2025-085208

Verify or expand the search:

Other trials of HSK21542

Trials testing the same drug.

NCT07186426 — A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthoped · Phase 3 · recruiting
NCT06593782 — Evaluating the Efficacy and Safety of HSK21542 Injection in Chemotherapy-induced Nausea and Vomiting · Phase 2 · not yet recruiting
NCT06359535 — An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting · Phase 4 · recruiting
NCT04999787 — A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects W · Phase 2 · completed
NCT04738357 — A Clinical Study to Evaluate Efficacy and Safety of HSK21542 for Postoperative Analgesia of Subjects Undergoing Elective · Phase 3 · completed

Other recruiting trials for Pruritus

Currently open trials in the same condition.

NCT06593392 — Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus · Phase 2 · recruiting
NCT06751056 — Cervical Traction to Reduce Gabaergic Medication Use for Neuropathic Itch · NA · recruiting
NCT06800755 — Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque · NA · recruiting
NCT06787794 — Reducing Itch With Hypnosis and Virtual Reality · NA · recruiting
NCT06488742 — The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis · NA · recruiting

Other Haisco Pharmaceutical Group Co., Ltd. trials

Trials by the same sponsor.

NCT07533786 — A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdomina · Phase 2 · not yet recruiting
NCT07519070 — A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44 · Phase 3 · not yet recruiting
NCT07503587 — Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07521345 — A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healt · Phase 1 · recruiting
NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05135390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Haisco Pharmaceutical Group Co., Ltd.
Last refreshed: 31 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05135390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing