Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients

Clinical Pharmacology of LT5001 Drug Product in Hemodialysis Patients With Uremic Pruritus to Assess the Safety, Local Tolerance and Pharmacokinetics

A Randomized, Double Blind, Placebo-Controlled study to assess the Safety, Local Tolerance, and Pharmacokinetics of LT5001 drug product in Hemodialysis Patients with Uremic Pruritus

Study Overview

• Status: Terminated
• Conditions: Uremic Pruritus
• Intervention / Treatment: Drug: LT5001; Drug: Placebo

Detailed Description

In Part A, patient participation is expected to last up to 63 days, including a 28-day screening period(consisting of a 7-day diary run-in to build baseline itch NRS) and a 36-day on study period (consisting of 56 total doses from Day 1 to Day 29, and a 7 day follow-up/EOS visit at Day 36).

In Part B, patient participation is expected to last up to 85 days, including a 28-day screening period (consisting of a 7-day diary run-in to build baseline itch NRS) and a 57-day on study treatment period.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female 20 to 75 years of age, inclusive, at the time of signing informed consent.
2. Patient must have been receiving in-center hemodialysis for ≥ 3 months and currently on a schedule of 3 times per week.
3. Patient must have had at least 2 urea reduction ratio (URR) measurements ≥ 65%, at least 2 single-pool Kt/V measurements ≥ 1.2, or 1 single-pool Kt/V measurement ≥ 1.2 and 1 URR measurement ≥ 65% on different dialysis days within the last 3 month period prior to the Screening Visit.
4. Body weight ≥ 40 kg (not to exceed 115 kg) and BMI ≥ 18.0 and ≤ 31.0 kg/m2 at screening and Day 1 (after hemodialysis).
5. History of pruritus > 4 weeks of duration
6. Females with childbearing potential (defined as women ≤50 years of age with a history of amenorrhea for <12 months prior to study entry) must agree to use effective methods of contraception from screening through the last dose of study drug.
7. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days, whichever is longer, after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 90 days after administration of the last dose of study drug.
8. Males must agree to not donate sperm from screening through 90 days, whichever is longer, after administration of the last dose of study drug.
9. Patient must have completed at least 6 days of Worst Itching Intensity NRS worksheets in the 7-day Diary run-in period and have a mean Worst Itching Intensity NRS score > 4 prior to randomization.
10. Patients must be able to complete questionnaires, understand the study procedures, and communicate effectively with the study personnel.

Exclusion Criteria:

1. History of alcohol abuse, illicit drug use, physical dependence to any opioid or narcotic, or any history of drug abuse or addiction within 6 months of screening.
2. History of major surgery or trauma within 12 weeks of screening in the judgement of the investigator, or surgery planned during the study.
3. Has received ultraviolet B treatment, opioid antagonists (eg, naloxone, naltrexone), or opioid mixed agonist-antagonist (eg, nalbuphine) within 30 days prior to the Screening Visit or anticipated to receive such treatment during the study.
4. Has had a significant alteration in dialysis regimen within 2 weeks of the Screening Visit or anticipated to be receiving nocturnal dialysis, home hemodialysis treatment, or kidney transplant during the study.
5. Has any known history of allergic reaction to opioids.
6. History of latest positive serology test for HBV (HBsAg) or HCV (anti-HCV) within 1 year prior randomization consistent with current infection. Confirmatory tests will be allowed at the discretion of the investigator to rule out false positives.
7. Has any known history of HIV.
8. Positive pregnancy test or is lactating.
9. Has required peritoneal dialysis.
10. Alanine aminotransferase and/or aspartate aminotransferase concentration > 2 x the ULN, or total bilirubin > 1.8 x ULN, or hemoglobin concentration < 9 g/dL at the Screening Visit.
11. Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives (if known) of the investigational drug's PK, PD, or biological activity (if known), whichever is longer, prior to first dose of study drug in this study or is currently participating in another clinical study.
12. Has received a vaccination within 3 days prior to administration of the first dose of study drug.
13. Has pruritus probably or definitely attributed to a cause other than renal disease or its complications such as atopic dermatitis, chronic urticarial, or hepatic pruritus caused by chronic liver disease.
14. Presence of skin infection (as defined by the investigator) on the area to be treated.
15. Any other condition or prior therapy that, in the investigator's opinion, would make the patient unsuitable for the study, or unable or unwilling to comply with the study procedures
16. Involved in the planning or conduct of this study.
17. Unwilling or unlikely to comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LT5001; Administered twice daily (maximum 6 g per time, morning and evening respectively)	Drug: LT5001; LT5001 is administered twice daily.
Placebo Comparator: Placebo; Administered twice daily (maximum 6 g per time, morning and evening respectively)	Drug: Placebo; LT5001 is administered twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Events With AE by Severity	The number of reported AE events by severity	Week 4
Number of Patients With AE by Severity	Adverse events (AEs) were collected and categorized by severity (mild, moderate, or severe) according to standard clinical criteria. The outcome measure is defined as the number of patients who experienced at least one adverse event of each severity level during the study period.	Week 4
The Number of Patients With AE by Causality	Adverse events were assessed for their causal relationship to the study treatment by the investigator and categorized as related or not related. The outcome measure is defined as the number of patients who experienced at least one adverse event in each causality category during the study period.	4 weeks
Number of AE Event by Causality	The number of reported events by causality	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Ctrough Exposure of LT5001 in Hemodialysis Patients.	The systemic trough (Ctrough) concentration of LT5001 was measured in hemodialysis patients at specified time points prior to the next scheduled dose using validated bioanalytical methods. The outcome measure is defined as the plasma concentration of LT5001 immediately before each dosing interval.	Week 4
Change in Mean Worst Itching Intensity From Baseline to the End of Week 4 Using NRS.	The intensity of itch will be measured using the Numerical Rating Scale (NRS), a standardized scale for assessing the worst itching over the past 24 hours. The scale ranges from 0 to 10, where 0 represents no itching and 10 represents the worst itching imaginable. Higher scores indicate worse itch severity. The outcome measure is defined as the change in mean worst itching intensity from baseline to the end of Week 4.	Week 4
Proportion of Patients With Changes in Numerical Rating Scale (>=2 Points, >=3 Points, >=4 Points) From Baseline	The Numerical Rating Scale (NRS) is an 11-point scale used to assess itch intensity, where scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst itch imaginable. A decrease in NRS score represents an improvement in itch severity. This outcome measures the proportion of patients who achieved a reduction of at least 2 points, 3 points, or 4 points from baseline in NRS score at Week 4.	Week 4
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Pruritus Scale at the End of Week 4.	The 5-D Pruritus Scale (5-D Itch Scale) is a multidimensional questionnaire assessing itching across five key domains: Duration, Degree, Direction, Disability, and Distribution, to comprehensively evaluate the impact of itch on daily life. The scale ranges from 5 to 25, with 5 representing no itch and 25 representing severe itch. Each domain is scored from 1 (lowest) to 5 (highest). Higher scores indicate worse itch and poorer itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in 5-D Pruritus Scale total score at the end of Week 4, with improvement reflected by a decrease in total score.	Week 4
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 4.	The Skindex-10 Scale is a multidimensional questionnaire assessing itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. Each of the 10 items is scored from 0 to 6, resulting in a total score ranging from 0 to 60, where 0 represents never bothered/no impact and 60 represents always bothered/severe impact. Higher scores indicate worst itch-related quality of life, whereas lower scores indicate better quality of life. The outcome measure is defined as the change from baseline in total Skindex-10 Scale Score at the end of Week 4, with improvement reflected by a decrease in total score.	Week 4

Collaborators and Investigators

• Sponsor: Lumosa Therapeutics Co., Ltd.
• Investigators: Study Director: June Kuo, Lumosa Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Hemodialysis; uremic pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: LT5001-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No