Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients (NCT04393675) | Clinical Trial Compass
TerminatedPhase 1/2
Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients
Stopped: Change in the clinical development plan
Taiwan18 participantsStarted 2020-05-14
Plain-language 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
Who can participate
Age range20 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.