Spots Global Cancer Trial Database for Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
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Trial Identification
Brief Title: Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals With End Stage Kidney Disease on Hemodialysis (PATH-2) With an Open-Label Extension
Study ID: NCT05836220
Study Description
Brief Summary: This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases. First, a placebo-controlled, double-blind phase where patients will be randomly assigned to either receive dose-titrated PLS240 or matching placebo for 27 weeks. After the completion of the double-blind phase, patients will be eligible to enroll in the open-label extension phase, where they will receive dose-titrated PLS240 for an additional 26 weeks. Throughout the duration of the study, patients will be expected to attend multiple study visits where an investigator will collect blood, preform electrocardiograms (ECGs) and physical exams, and further assess the safety and efficacy of PLS240.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site Number: USA039-2, Anaheim, California, United States
Site Number: USA001-2, Chula Vista, California, United States
Site Number: USA003-2, El Centro, California, United States
Site Number: USA020-2, Escondido, California, United States
Site Number: USA042-2, Fresno, California, United States
Site Number: USA034-2, Fullerton, California, United States
Site Number: USA046-2, Glendale, California, United States
Site Number: USA019-2, Granada Hills, California, United States
Site Number: USA005-2, La Mesa, California, United States
Site Number: USA044-2, Lancaster, California, United States
Site Number: USA030-2, Los Angeles, California, United States
Site Number: USA043-2, Los Angeles, California, United States
Site Number: USA022-2, Moorpark, California, United States
Site Number: USA049-2, Northridge, California, United States
Site Number: USA033-2, Northridge, California, United States
Site Number: USA018-2, San Dimas, California, United States
Site Number: USA021-2, Tarzana, California, United States
Site Number: USA056-2, Tarzana, California, United States
Site Number: USA052-2, Victorville, California, United States
Site Number: USA023-2, Arvada, Colorado, United States
Site Number: USA031-2, Aurora, Colorado, United States
Site Number: USA017-2, Middlebury, Connecticut, United States
Site Number: USA015-2, Newark, Delaware, United States
Site Number: USA041-2, Boca Raton, Florida, United States
Site Number: USA004-2, Fort Myers, Florida, United States
Site Number: USA002-2, Hollywood, Florida, United States
Site Number: USA035-2, South Miami, Florida, United States
Site Number: USA013-2, Columbus, Georgia, United States
Site Number: USA028-2, Mishawaka, Indiana, United States
Site Number: USA024-2, Wichita, Kansas, United States
Site Number: USA054-2, New Orleans, Louisiana, United States
Site Number: USA025-2, Kalamazoo, Michigan, United States
Site Number: USA048-2, Roseville, Michigan, United States
Site Number: USA016-2, Minneapolis, Minnesota, United States
Site Number: USA007-2, Amherst, New York, United States
Site Number: USA053-2, Charlotte, North Carolina, United States
Site Number: USA026-2, Durham, North Carolina, United States
Site Number: USA009-2, Toledo, Ohio, United States
Site Number: USA045-2, Roseburg, Oregon, United States
Site Number: USA010-2, Spartanburg, South Carolina, United States
Site Number: USA027-2, Knoxville, Tennessee, United States
Site Number: USA011-2, El Paso, Texas, United States
Site Number: USA055-2, Greenville, Texas, United States
Site Number: USA029-2, Live Oak, Texas, United States
Site Number: USA012-2, San Antonio, Texas, United States
Site Number: USA008-2, San Antonio, Texas, United States
Site Number: USA006-2, Waxahachie, Texas, United States
Site Number: USA038-2, Saint George, Utah, United States
Site Number: USA051-2, Fairfax, Virginia, United States
Site Number: USA037-2, Virginia Beach, Virginia, United States
Site Number: BGR003-2, Lom, Montana, Bulgaria
Site Number: BGR001-2, Gabrovo, , Bulgaria
Site Number: BGR002-2, Ruse, , Bulgaria
Site Number: BGR004-2, Varna, , Bulgaria
Site Number: POL001-2, ÅĆ³dÅŗ, LĆ³dzkie, Poland
Site Number: POL004-2, Olkusz, Malopolskie, Poland
Site Number: POL005-2, Warszawa, Mazowieckie, Poland
Site Number: POL003-2, Pszczyna, Slaskie, Poland
Site Number: POL002-2, PoznaÅ, Wielkopolskie, Poland
Site Number: PRT002-2, CovilhĆ£, Castelo Branco, Portugal
Site Number: PRT001-2, Carnaxide, , Portugal
Site Number: PRT003-2, Lisboa, , Portugal
Site Number: SRB005-2, Beograd, Belgrade, Serbia
Site Number: SRB003-2, Belgrade, , Serbia
Site Number: SRB001-2, KruŔevac, , Serbia
Site Number: SRB002-2, NiÅ”, , Serbia
Site Number: SRB004-2, Užice, , Serbia
Site Number: ESP003-2, CĆ³rdoba, Cordoba, Spain
Site Number: ESP005-2, Manises, Valencia, Spain
Contact Details
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