Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
Public ClinicalTrials.gov record NCT05832931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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-1) With an Open-Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05832931
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 362 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 28, 2023 (Actual)
- Primary completion
- Jul 28, 2025 (Actual)
- Completion
- Jul 28, 2025 (Actual)
- Last update posted
- Sep 9, 2025
2023 – 2025
United States locations
- U.S. sites
- 49
- U.S. states
- 21
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Number: USA016-1 | Pine Bluff | Arkansas | 71603-4921 | — |
| Site Number: USA032-1 | Anaheim | California | 92801-2817 | — |
| Site Number: USA031-1 | Beverly Hills | California | 90211-2921 | — |
| Site Number: USA020-1 | Fairfield | California | 94534 | — |
| Site Number: USA023-1 | Fullerton | California | 92835-3639 | — |
| Site Number: USA030-1 | Glendale | California | 91206-4015 | — |
| Site Number: USA045-1 | Oxnard | California | 93036-3075 | — |
| Site Number: USA046-1 | Riverside | California | 92505-3081 | — |
| Site Number: USA035-1 | Salinas | California | 93901-4446 | — |
| Site Number: USA001-1 | San Diego | California | 92111-3636 | — |
| Site Number: USA021-1 | San Diego | California | 92111-3636 | — |
| Site Number: USA019-1 | San Dimas | California | 91773-3537 | — |
| Site Number: USA036-1 | Whittier | California | 90606-3007 | — |
| Site Number: USA018-1 | Denver | Colorado | 80210-5073 | — |
| Site Number: USA003-1 | Lone Tree | Colorado | 80124-3191 | — |
| Site Number: USA009-1 | Hartford | Connecticut | 06112-1272 | — |
| Site Number: USA042-1 | Coral Gables | Florida | 33134-2049 | — |
| Site Number: USA055-1 | Coral Gables | Florida | 33134-2060 | — |
| Site Number: USA034-1 | Hollywood | Florida | 33024-2776 | — |
| Site Number: USA053-1 | Atlanta | Georgia | 30342-1626 | — |
| Site Number: USA013-1 | Dalton | Georgia | 30720 | — |
| Site Number: USA027-1 | Boise | Idaho | 83706-1248 | — |
| Site Number: USA007-1 | Shelbyville | Indiana | 46176-8591 | — |
| Site Number: USA026-1 | Baton Rouge | Louisiana | 70808-4791 | — |
| Site Number: USA015-1 | Columbus | Mississippi | 39705-2024 | — |
| Site Number: USA028-1 | Oxford | Mississippi | 38655 | — |
| Site Number: USA022-1 | Kansas City | Missouri | 64111-2925 | — |
| Site Number: USA017-1 | Las Vegas | Nevada | 89107-6100 | — |
| Site Number: USA010-1 | Jersey City | New Jersey | 07305 | — |
| Site Number: USA008-1 | Gallup | New Mexico | 87301-5611 | — |
| Site Number: USA039-1 | Manhasset | New York | 11030-3802 | — |
| Site Number: USA011-1 | The Bronx | New York | 10461-2755 | — |
| Site Number: USA052-1 | Charlotte | North Carolina | 28277-9720 | — |
| Site Number: USA043-1 | Greenville | North Carolina | 27834-4300 | — |
| Site Number: USA033-1 | Winston-Salem | North Carolina | 27103-7154 | — |
| Site Number: USA040-1 | Spartanburg | South Carolina | 29301-5085 | — |
| Site Number: USA049-1 | Knoxville | Tennessee | 37924-3606 | — |
| Site Number: USA037-1 | Arlington | Texas | 76015-2363 | — |
| Site Number: USA024-1 | Austin | Texas | 78751-3014 | — |
| Site Number: USA056-1 | Fort Worth | Texas | 76110-1865 | — |
| Site Number: USA014-1 | Houston | Texas | 77054-3835 | — |
| Site Number: USA012-1 | Houston | Texas | 77074-1802 | — |
| Site Number: USA025-1 | McAllen | Texas | 78503-1251 | — |
| Site Number: USA029-1 | San Antonio | Texas | 78202-2916 | — |
| Site Number: USA005-1 | San Antonio | Texas | 78229-4605 | — |
| Site Number: USA004-1 | San Antonio | Texas | 78251-4498 | — |
| Site Number: USA002-1 | The Woodlands | Texas | 77384-8042 | — |
| Site Number: USA006-1 | Norfolk | Virginia | 23504-2303 | — |
| Site Number: USA050-1 | Wauwatosa | Wisconsin | 53226-4339 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05832931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05832931 live on ClinicalTrials.gov.