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

NCT04393675 | Terminated Phase 1 Results DMC

• 1 other identifier: LT5001-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uremic Pruritus

Keywords

uremic pruritus; Hemodialysis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Systemic Ctrough Exposure of LT5001 in Hemodialysis Patients.

  Week 4

• Change in Mean Worst Itching Intensity From Baseline to the End of Week 4 Using NRS.

  Week 4

• Proportion of Patients With Changes in Numerical Rating Scale (>=2 Points, >=3 Points, >=4 Points) From Baseline

  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.

  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.

  Week 4

Study Arms (2)

LT5001

ACTIVE COMPARATOR

Administered twice daily (maximum 6 g per time, morning and evening respectively)

Drug: LT5001

Placebo

PLACEBO COMPARATOR

Administered twice daily (maximum 6 g per time, morning and evening respectively)

Drug: Placebo

Interventions

LT5001 DRUG

LT5001 is administered twice daily.

LT5001

Placebo DRUG

LT5001 is administered twice daily.

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 20 to 75 years of age, inclusive, at the time of signing informed consent.
• Patient must have been receiving in-center hemodialysis for ≥ 3 months and currently on a schedule of 3 times per week.
• 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.
• 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).
• History of pruritus \> 4 weeks of duration
• 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.
• 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.
• Males must agree to not donate sperm from screening through 90 days, whichever is longer, after administration of the last dose of study drug.
• 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.
• Patients must be able to complete questionnaires, understand the study procedures, and communicate effectively with the study personnel.

You may not qualify if:

• 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.
• History of major surgery or trauma within 12 weeks of screening in the judgement of the investigator, or surgery planned during the study.
• 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.
• 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.
• Has any known history of allergic reaction to opioids.
• 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.
• Has any known history of HIV.
• Positive pregnancy test or is lactating.
• Has required peritoneal dialysis.
• 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.
• 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.
• Has received a vaccination within 3 days prior to administration of the first dose of study drug.
• 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.
• Presence of skin infection (as defined by the investigator) on the area to be treated.
• 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

Sponsors & Collaborators

• Lumosa Therapeutics Co., Ltd.: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Results Point of Contact

• Title: Claire Sun
• Organization: Lumosa Therapeutics

claire_sun@lumosa.com.tw

+886-2-2655-7918

Study Officials

• June Kuo

  Lumosa Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 14, 2020
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Locations

TW (1)