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Completed Phase 3 Interventional

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2

ClinicalTrials.gov ID: NCT05836220

Public ClinicalTrials.gov record NCT05836220. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 4:56 AM EDT

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-2) 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
NCT05836220
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pathalys Pharma
Industry
Enrollment
412 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
May 15, 2023 (Actual)
Primary completion
Aug 5, 2025 (Actual)
Completion
Aug 5, 2025 (Actual)
Last update posted
Sep 9, 2025

2023 – 2025

United States locations

U.S. sites
50
U.S. states
20
U.S. cities
46
Facility City State ZIP Site status
Site Number: USA039-2 Anaheim California 92801-6731 —
Site Number: USA001-2 Chula Vista California 91910-3813 —
Site Number: USA020-2 Escondido California 92025-4402 —
Site Number: USA042-2 Fresno California 93720-3389 —
Site Number: USA034-2 Fullerton California 92832-3037 —
Site Number: USA046-2 Glendale California 91205-3313 —
Site Number: USA019-2 Granada Hills California 91344-7407 —
Site Number: USA005-2 La Mesa California 91942-3017 —
Site Number: USA044-2 Lancaster California 93534-2831 —
Site Number: USA030-2 Los Angeles California 90022-4302 —
Site Number: USA043-2 Los Angeles California 90033 —
Site Number: USA022-2 Moorpark California 93021-3352 —
Site Number: USA049-2 Northridge California 91324-2927 —
Site Number: USA033-2 Northridge California 91324-3528 —
Site Number: USA003-2 San Diego California 92111-3636 —
Site Number: USA018-2 San Dimas California 91773-3539 —
Site Number: USA056-2 Tarzana California 91356-2806 —
Site Number: USA021-2 Tarzana California 91356-3647 —
Site Number: USA052-2 Victorville California 92395-8322 —
Site Number: USA023-2 Arvada Colorado 80002-3714 —
Site Number: USA031-2 Aurora Colorado 80045-7202 —
Site Number: USA017-2 Middlebury Connecticut 06762-2843 —
Site Number: USA015-2 Newark Delaware 19713-2081 —
Site Number: USA004-2 Fort Myers Florida 33908-4154 —
Site Number: USA002-2 Hollywood Florida 33024-2776 —
Site Number: USA041-2 Orlando Florida 32801 —
Site Number: USA035-2 South Miami Florida 33143-5522 —
Site Number: USA013-2 Columbus Georgia 31904-3603 —
Site Number: USA028-2 Mishawaka Indiana 46545-3519 —
Site Number: USA024-2 Wichita Kansas 67214-2944 —
Site Number: USA054-2 New Orleans Louisiana 70112 —
Site Number: USA048-2 Detroit Michigan 48236-2169 —
Site Number: USA025-2 Kalamazoo Michigan 49007-3889 —
Site Number: USA016-2 Minneapolis Minnesota 55404-1212 —
Site Number: USA007-2 Amherst New York 14228-2792 —
Site Number: USA053-2 Charlotte North Carolina 28208-3876 —
Site Number: USA026-2 Durham North Carolina 27704-2147 —
Site Number: USA009-2 Toledo Ohio 43606-1171 —
Site Number: USA045-2 Roseburg Oregon 97471-6214 —
Site Number: USA010-2 Greenville South Carolina 29605-4019 —
Site Number: USA027-2 Knoxville Tennessee 37923-3624 —
Site Number: USA011-2 El Paso Texas 79925-4828 —
Site Number: USA029-2 Live Oak Texas 78233-4767 —
Site Number: USA055-2 Prosper Texas 75078-1411 —
Site Number: USA012-2 San Antonio Texas 78221-3019 —
Site Number: USA008-2 San Antonio Texas 78251-4125 —
Site Number: USA006-2 Waxahachie Texas 75165-1399 —
Site Number: USA038-2 St. George Utah 84790-5898 —
Site Number: USA051-2 Fairfax Virginia 22033-1907 —
Site Number: USA037-2 Norfolk Virginia 23507-1901 —

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 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05836220, 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 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05836220 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →