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Clinical Trial Details

Trial ID: L1446
Source ID: NCT05836220
Associated Drug: Pls240
Title: Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
Acronym: PATH-2
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Secondary Hyperparathyroidism|End Stage Kidney Disease
Interventions: DRUG: PLS240|DRUG: Placebo|DRUG: Open-Label Extension PLS240
Outcome Measures: Primary: The proportion of PLS240 treated participants compared to the portion of placebo treated participants with a ≥30% decrease in mean iPTH, Double-Blind Phase only. 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 AE's, up to week 28|Open-Label Phase: Number of SAE's, up to week 28 |
Sponsor/Collaborators: Sponsor: Pathalys Pharma | Collaborators: Launch Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 412
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-15
Completion Date: 2025-07
Results First Posted:
Last Update Posted: 2025-03-21
Locations: Site Number: USA039-2, Anaheim, California, 92801-6731, United States|Site Number: USA001-2, Chula Vista, California, 91910-3813, United States|Site Number: USA020-2, Escondido, California, 92025-4402, United States|Site Number: USA042-2, Fresno, California, 93720-3389, United States|Site Number: USA034-2, Fullerton, California, 92832-3037, United States|Site Number: USA046-2, Glendale, California, 91205-3313, United States|Site Number: USA019-2, Granada Hills, California, 91344-7407, United States|Site Number: USA005-2, La Mesa, California, 91942-3017, United States|Site Number: USA044-2, Lancaster, California, 93534-2831, United States|Site Number: USA030-2, Los Angeles, California, 90022-4302, United States|Site Number: USA043-2, Los Angeles, California, 90033, United States|Site Number: USA022-2, Moorpark, California, 93021-3352, United States|Site Number: USA049-2, Northridge, California, 91324-2927, United States|Site Number: USA033-2, Northridge, California, 91324-3528, United States|Site Number: USA003-2, San Diego, California, 92111-3636, United States|Site Number: USA018-2, San Dimas, California, 91773-3539, United States|Site Number: USA056-2, Tarzana, California, 91356-2806, United States|Site Number: USA021-2, Tarzana, California, 91356-3647, United States|Site Number: USA052-2, Victorville, California, 92395-8322, United States|Site Number: USA023-2, Arvada, Colorado, 80002-3714, United States|Site Number: USA031-2, Aurora, Colorado, 80045-7202, United States|Site Number: USA017-2, Middlebury, Connecticut, 06762-2843, United States|Site Number: USA015-2, Newark, Delaware, 19713-2081, United States|Site Number: USA004-2, Fort Myers, Florida, 33908-4154, United States|Site Number: USA002-2, Hollywood, Florida, 33024-2776, United States|Site Number: USA041-2, Orlando, Florida, 32801, United States|Site Number: USA035-2, South Miami, Florida, 33143-5522, United States|Site Number: USA013-2, Columbus, Georgia, 31904-3603, United States|Site Number: USA028-2, Mishawaka, Indiana, 46545-3519, United States|Site Number: USA024-2, Wichita, Kansas, 67214-2944, United States|Site Number: USA054-2, New Orleans, Louisiana, 70112, United States|Site Number: USA048-2, Detroit, Michigan, 48236-2169, United States|Site Number: USA025-2, Kalamazoo, Michigan, 49007-3889, United States|Site Number: USA016-2, Minneapolis, Minnesota, 55404-1212, United States|Site Number: USA007-2, Amherst, New York, 14228-2792, United States|Site Number: USA053-2, Charlotte, North Carolina, 28208-3876, United States|Site Number: USA026-2, Durham, North Carolina, 27704-2147, United States|Site Number: USA009-2, Toledo, Ohio, 43606-1171, United States|Site Number: USA045-2, Roseburg, Oregon, 97471-6214, United States|Site Number: USA010-2, Greenville, South Carolina, 29605-4019, United States|Site Number: USA027-2, Knoxville, Tennessee, 37923-3624, United States|Site Number: USA011-2, El Paso, Texas, 79925-4828, United States|Site Number: USA029-2, Live Oak, Texas, 78233-4767, United States|Site Number: USA055-2, Prosper, Texas, 75078-1411, United States|Site Number: USA012-2, San Antonio, Texas, 78221-3019, United States|Site Number: USA008-2, San Antonio, Texas, 78251-4125, United States|Site Number: USA006-2, Waxahachie, Texas, 75165-1399, United States|Site Number: USA038-2, Saint George, Utah, 84790-5898, United States|Site Number: USA051-2, Fairfax, Virginia, 22033-1907, United States|Site Number: USA037-2, Norfolk, Virginia, 23507-1901, United States|Site Number: BGR003-2, Lom, Montana, 3600, Bulgaria|Site Number: BGR001-2, Gabrovo, 5300, Bulgaria|Site Number: BGR002-2, Ruse, 7002, Bulgaria|Site Number: BGR004-2, Varna, 9000, Bulgaria|Site Number: POL004-2, Tomaszów Mazowiecki, Lódzkie, 97-200, Poland|Site Number: POL001-2, Łódź, Lódzkie, 90-242, Poland|Site Number: POL005-2, Warszawa, Mazowieckie, 02-758, Poland|Site Number: POL002-2, Poznań, Wielkopolskie, 60-214, Poland|Site Number: PRT002-2, Covilhã, Castelo Branco, 6200-000, Portugal|Site Number: PRT001-2, Carnaxide, 2790-134, Portugal|Site Number: PRT003-2, Lisboa, 1250-203, Portugal|Site Number: SRB005-2, Beograd, Belgrade, 11080, Serbia|Site Number: SRB003-2, Belgrade, 11000, Serbia|Site Number: SRB001-2, Kruševac, 37000, Serbia|Site Number: SRB002-2, Niš, 18000, Serbia|Site Number: SRB004-2, Užice, 31000, Serbia|Site Number: ESP003-2, Córdoba, Cordoba, 14004, Spain|Site Number: ESP005-2, Manises, Valencia, 46940, Spain
URL: https://clinicaltrials.gov/show/NCT05836220

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D184 Simvastatin small molecule DB00641 Details
D445 Dapagliflozin small molecule DB06292 Details
D039 Cholecalciferol small molecule DB00169 Details