Treatment for severe itching in dialysis patients

A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus

This study is testing a new treatment called QLG2198 to see if it can help reduce severe itching in adults who are on dialysis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06446310 on ClinicalTrials.gov

What this trial studies

This multicenter clinical trial evaluates the efficacy and safety of QLG2198 in reducing moderate-to-severe pruritus in adult patients undergoing hemodialysis. The study consists of a 12-week double-blind period followed by a 14-week open-label extension and a 1-week follow-up. Participants will receive QLG2198 or a placebo three times a week at the end of each dialysis session, with the dosage based on their dry body weight. The total duration for each participant is approximately 31 to 32 weeks, including a screening period.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic kidney disease on hemodialysis for at least 12 weeks and experiencing moderate-to-severe pruritus.

Not a fit: Patients who have localized itch only on their palms or those with pruritus limited to dialysis sessions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate itching for patients undergoing hemodialysis, improving their quality of life.

How similar studies have performed: While there have been studies on pruritus in dialysis patients, the specific approach with QLG2198 is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Jieyang People's Hospital — Jieyang, Guangdong, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Zuo Li — Peking University People's Hospital
• Study coordinator: Wu Yidi, M.M

Conditions Uremic Pruritus