Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
Qilu Pharmaceutical (Hainan) Co., Ltd.
194 participants
Jun 18, 2024
INTERVENTIONAL
Conditions
Summary
This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.
Eligibility
Inclusion Criteria4
- Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
- If female, is not pregnant, or nursing.
- agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
- Subjects with a prescription dry body weight between 40 and 100 kg
Exclusion Criteria8
- Planned to receive a kidney transplant during the study.
- Has localised itch restricted to the palms of the hands.
- Has pruritus only during the dialysis session
- Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
- Subject is receiving ongoing ultraviolet treatment .
- Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
- Known or suspected history of alcohol or drug abuse/dependence within 12 months prior to screening.
- New or change of treatment received for itch within 2 weeks prior to screening.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.
Participants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06446310