Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1505
Source ID: NCT05832931
Associated Drug: Pls240
Title: Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
Acronym: PATH-1
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Secondary Hyperparathyroidism|End-stage Kidney Disease (ESKD)
Interventions: DRUG: PLS240|DRUG: Placebo|DRUG: Open-Label Extension PLS240
Outcome Measures: Primary: Double-Blind Phase: Proportion of PLS240 treated participants compared to placebo treated participants with a ≥30% decrease in mean iPTH, This measurement will be calculated based on the Efficacy Assessment Period (Weeks 22 - 27) relative to the mean baseline iPTH (all Active Screening and predose Day 1 iPTH values)., each visit from screening through week 27|Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <7.5 mg/dL, up to week 28|Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <8.3 mg/dL, up to week 28|Open-Label Phase: Number of Adverse Events (AEs), up to week 28|Open-Label Phase: Number of Serious Adverse Events (SAEs), up to week 28 |
Sponsor/Collaborators: Sponsor: Pathalys Pharma | Collaborators: Launch Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 362
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-28
Completion Date: 2025-07
Results First Posted:
Last Update Posted: 2025-03-21
Locations: Site Number: USA016-1, Pine Bluff, Arkansas, 71603-4921, United States|Site Number: USA032-1, Anaheim, California, 92801-2817, United States|Site Number: USA031-1, Beverly Hills, California, 90211-2921, United States|Site Number: USA020-1, Fairfield, California, 94534, United States|Site Number: USA023-1, Fullerton, California, 92835-3639, United States|Site Number: USA030-1, Glendale, California, 91206-4015, United States|Site Number: USA045-1, Oxnard, California, 93036-3075, United States|Site Number: USA046-1, Riverside, California, 92505-3081, United States|Site Number: USA035-1, Salinas, California, 93901-4446, United States|Site Number: USA001-1, San Diego, California, 92111-3636, United States|Site Number: USA021-1, San Diego, California, 92111-3636, United States|Site Number: USA019-1, San Dimas, California, 91773-3537, United States|Site Number: USA036-1, Whittier, California, 90606-3007, United States|Site Number: USA018-1, Denver, Colorado, 80210-5073, United States|Site Number: USA003-1, Lone Tree, Colorado, 80124-3191, United States|Site Number: USA009-1, Hartford, Connecticut, 06112-1272, United States|Site Number: USA042-1, Coral Gables, Florida, 33134-2049, United States|Site Number: USA055-1, Coral Gables, Florida, 33134-2060, United States|Site Number: USA034-1, Hollywood, Florida, 33024-2776, United States|Site Number: USA053-1, Atlanta, Georgia, 30342-1626, United States|Site Number: USA013-1, Dalton, Georgia, 30720, United States|Site Number: USA027-1, Boise, Idaho, 83706-1248, United States|Site Number: USA007-1, Shelbyville, Indiana, 46176-8591, United States|Site Number: USA026-1, Baton Rouge, Louisiana, 70808-4791, United States|Site Number: USA015-1, Columbus, Mississippi, 39705-2024, United States|Site Number: USA028-1, Oxford, Mississippi, 38655, United States|Site Number: USA022-1, Kansas City, Missouri, 64111-2925, United States|Site Number: USA017-1, Las Vegas, Nevada, 89107-6100, United States|Site Number: USA010-1, Jersey City, New Jersey, 07305, United States|Site Number: USA008-1, Gallup, New Mexico, 87301-5611, United States|Site Number: USA011-1, Bronx, New York, 10461-2755, United States|Site Number: USA039-1, Manhasset, New York, 11030-3802, United States|Site Number: USA052-1, Charlotte, North Carolina, 28277-9720, United States|Site Number: USA043-1, Greenville, North Carolina, 27834-4300, United States|Site Number: USA033-1, Winston-Salem, North Carolina, 27103-7154, United States|Site Number: USA040-1, Spartanburg, South Carolina, 29301-5085, United States|Site Number: USA049-1, Knoxville, Tennessee, 37924-3606, United States|Site Number: USA037-1, Arlington, Texas, 76015-2363, United States|Site Number: USA024-1, Austin, Texas, 78751-3014, United States|Site Number: USA056-1, Fort Worth, Texas, 76110-1865, United States|Site Number: USA014-1, Houston, Texas, 77054-3835, United States|Site Number: USA012-1, Houston, Texas, 77074-1802, United States|Site Number: USA025-1, McAllen, Texas, 78503-1251, United States|Site Number: USA029-1, San Antonio, Texas, 78202-2916, United States|Site Number: USA005-1, San Antonio, Texas, 78229-4605, United States|Site Number: USA004-1, San Antonio, Texas, 78251-4498, United States|Site Number: USA002-1, The Woodlands, Texas, 77384-8042, United States|Site Number: USA006-1, Norfolk, Virginia, 23504-2303, United States|Site Number: USA050-1, Wauwatosa, Wisconsin, 53226-4339, United States|Site Number: BGR003-1, Sofia, Sofia-Grad, 1309, Bulgaria|Site Number: BGR004-1, Sofia, Sofia-Grad, 1431, Bulgaria|Site Number: BGR002-1, Blagoevgrad, 2700, Bulgaria|Site Number: BGR001-1, Plovdiv, 4002, Bulgaria|Site Number: POL005-1, Oleśnica, Dolnoslaskie, 56-400, Poland|Site Number: POL002-1, Zyrardow, Mazowieckie, 96-300, Poland|Site Number: PRT003-1, Portimão, Faro, 8500-311, Portugal|Site Number: PRT001-1, Carregado, Lisboa, 2580-588, Portugal|Site Number: PRT002-1, Forte Da Casa, Lisboa, 2625-384, Portugal|Site Number: SRB001-1, Belgrade, 11000, Serbia|Site Number: SRB003-1, Kragujevac, 34000, Serbia|Site Number: SRB005-1, Novi Sad, 21000, Serbia|Site Number: SRB002-1, Zaječar, 19000, Serbia|Site Number: ESP001-1, Lleida, 25198, Spain|Site Number: ESP004-1, Madrid, 28034, Spain|Site Number: ESP005-1, Madrid, 28046, Spain|Site Number: ESP003-1, Pamplona, 31008, Spain|Site Number: ESP006-1, Sevilla, 41009, Spain|Site Number: ESP002-1, Valencia, 46014, Spain
URL: https://clinicaltrials.gov/show/NCT05832931

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress