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Secondary HyperparathyroidismPhase 3PATH-1NCT05832931

Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1

A Phase 3 study testing PLS240 and Open-Label Extension PLS240 in people with Secondary Hyperparathyroidism and End-stage Kidney Disease (ESKD), run by Pathalys Pharma at 68 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
PLS240 and Open-Label Extension PLS240
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
362 participants
Where
68 sitesin 6 countries
Study dates
28 Apr 2023to 28 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 - 80 years at time of informed consent.
  • Prescribed hemodialysis for 3 times per week and on therapy for at least 3 months and has a delivered Kt/V≥1.2 within 4 weeks prior to signing the ICF.
  • Pre-dialysis central laboratory iPTH must be ≥400 pg/mL on at least two assessments performed at 2 visits, at least 1 week apart during the Active Screening period. iPTH may be tested up to 4 times.
  • at least performed at least a week after the previous iPTH.
  • Pre-dialysis central laboratory cCa must be ≥8.3 mg/dL on at least one assessment performed during the Active Screening period. cCa may be tested up to 3 times during the Active Screening period.
  • Dialysate calcium concentration ≥2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to signing the ICF.
Show all 17Show fewer
  • Participants receiving active Vitamin D sterols (e.g., doxercalciferol or calcitriol) to manage SHPT must be on a stable dose (e.g., maximum dose change ≤50%), in the opinion of the investigator or sub-investigator, within the 2 months prior to signing the ICF, remain stable, as defined as no increase in dose, through the screening period, and be expected to maintain a stable dose, as defined as no increase in dose, for the duration of the study.
  • Participants receiving phosphate binders must be on a stable dose (e.g., maximum dose change ≤50%), in the opinion of the investigator or sub-investigator, within the 2 months prior to signing the ICF, remain stable through the screening period, and be expected to maintain stable dose for the duration of the study.
  • Participants receiving calcium supplements must be on a stable dose (e.g., maximum dose change ≤50%), in the opinion of the investigator or sub-investigator, within the 2 months prior to signing the ICF and remain stable through the screening period.
  • Female participants who are post-menopausal ('post-menopausal' women have had no menses for the previous year and are over the age of 50 years), or surgically sterilized, or have a medical condition that prevents pregnancy, or commit to remain abstinent during the study and for 2 weeks after the last dose of the investigational product (IP), or are willing to use highly effective contraception during the study and for 2 weeks after the last dose of IP. Women of child-bearing potential must have a negative serum pregnancy test during the screening period.
  • Male participants who are willing to use highly effective contraception when sexually active and will not donate sperm during the treatment phase and for 2 weeks after the last dose of IP.
  • Voluntarily given written informed consent to participate in this study.
  • Agrees to not participate in another study of an investigational agent during the study
  • To be eligible for inclusion into the Open-Label Extension Phase of the study, participants must fulfill the additional following criteria at the time of entry into the Open-Label Extension Phase:
  • Have successfully completed the course of treatment and final safety follow-up visit of the Double-Blind Phase.
  • Voluntarily given written informed consent to participate in the Open-Label Extension Phase of the study.
  • Prescribed hemodialysis for 3 times per week. 16. Continue to meet Inclusion Criteria 9, 10, and 12.

Who cannot join

  • Diagnosis of primary hyperparathyroidism.
  • Pre-dialysis central laboratory Active Screening iPTH >1500 pg/mL on two or more occasions. iPTH may be tested up to 4 times during the Active Screening period.
  • History of parathyroid intervention including parathyroidectomy (PTx) and percutaneous ethanol injection therapy (PEIT) within 26 weeks before signing the ICF.
  • Treatment with any prohibited medication as defined in Section 8.3.1.
  • Anticipated or scheduled parathyroidectomy during the study period.
  • Planned living-related or living-unrelated kidney transplant during the study period.
Show all 35Show fewer
  • Change in mode of dialysis (e.g., from hemodialysis to hemodiafiltration, peritoneal dialysis to hemodialysis, at home to in center dialysis), dialysate Ca concentration, or prescribed dialysis treatment time within 4 weeks before signing the ICF.
  • Noncompliant with hemodialysis (i.e., missing more than 2 dialysis sessions within 8 weeks prior to signing the ICF, unless absence is due to hospitalization or dialysis-access procedures).
  • Clinically significant abnormalities on screening laboratory tests (may repeat abnormal laboratory tests) according to the Investigator including but not limited to the following:
  • Serum albumin ≤3.0 g/dL
  • Serum magnesium <1.5 mg/dL
  • Serum P >8.0 mg/dL
  • Hemoglobin <8.5 g/dL
  • Platelet count <100,000 x106/L
  • Serum transaminase (alanine transaminase [ALT] or serum glutamic pyruvic transaminase [SGPT], alanine transaminase [AST] or serum glutamic oxaloacetic transaminase [SGOT]) ≥2.5 times the upper limit of normal (ULN) during Active Screening.
  • Diagnosed with an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access intervention, within 30 days prior to signing the TCF, or otherwise unstable in the judgment of the investigator.
  • History of malignancy within the last 2 years prior to signing the ICF (except squamous or basal cell skin cancers, or cervical carcinoma in situ).
  • Recent history (within 4 weeks prior to signing the ICF) of angina pectoris with symptoms that occur at rest or minimal activity. Chest pain on dialysis (within 8 weeks prior to signing the ICF) unless evaluated by a cardiologist with documentation that the chest pain is not due to cardiac ischemia.
  • History of New York Heart Association (NYHA) Functional Class 3 or 4 heart failure.
  • History of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 4 months prior to signing the ICF.
  • Stroke (cerebral infarction or cerebral hemorrhage) within 6 months prior to signing the ICF.
  • Participant is receiving treatment for a seizure disorder or has a history of a seizure within 12 weeks prior to signing the ICF.
  • Poorly controlled diabetes mellitus, in the judgment of the investigator or sub-investigator.
  • Poorly controlled hypertension (defined as post-dialysis [seated if available] systolic pressure >180 mmHg or diastolic pressure >110 mmHg) at 2 or more dialysis sessions during the 2 weeks prior to signing the ICF.
  • Enrolled in other invasive investigational device or investigational drug trials, within at least 30 days prior to signing the ICF or are receiving other investigational agents (experimental dialysis machines are acceptable).
  • History of symptomatic ventricular dysrhythmias or Torsade de Pointes.
  • History of or family history of long QT syndrome.
  • QTcF >500 msec on screening ECG.
  • Pregnant or breast feeding.
  • Prior exposure or hypersensitivity to PLS240 or any of its components.
  • Current, recent, or suspected infection with SARS-CoV-2/COVID-19 within 4 weeks prior to signing the ICF.
  • In the opinion of the investigator, any disorder that would interfere with understanding and giving informed consent, or compliance with protocol requirements.
  • Participants must be excluded from the Open-Label Extension Phase of the study, in case of the following at the time of entry into the Open-Label Extension Phase:
  • In the opinion of the investigator, continuation into the Open-Label Extension Phase is not considered safe and/or feasible.
  • Continues to meet Exclusion Criterion #5.

Trial locations and contacts

68 sites in 6 countries.

68 sites in 6 countries

United States49 sites

  • Site Number: USA032-1

    Anaheim, California, 92801-2817

  • Site Number: USA037-1

    Arlington, Texas, 76015-2363

  • Site Number: USA053-1

    Atlanta, Georgia, 30342-1626

  • Site Number: USA024-1

    Austin, Texas, 78751-3014

  • Site Number: USA026-1

    Baton Rouge, Louisiana, 70808-4791

  • Site Number: USA031-1

    Beverly Hills, California, 90211-2921

  • Site Number: USA027-1

    Boise, Idaho, 83706-1248

  • Site Number: USA052-1

    Charlotte, North Carolina, 28277-9720

  • Site Number: USA015-1

    Columbus, Mississippi, 39705-2024

  • Site Number: USA042-1

    Coral Gables, Florida, 33134-2049

  • Site Number: USA055-1

    Coral Gables, Florida, 33134-2060

  • Site Number: USA013-1

    Dalton, Georgia, 30720

  • Site Number: USA018-1

    Denver, Colorado, 80210-5073

  • Site Number: USA020-1

    Fairfield, California, 94534

  • Site Number: USA056-1

    Fort Worth, Texas, 76110-1865

  • Site Number: USA023-1

    Fullerton, California, 92835-3639

  • Site Number: USA008-1

    Gallup, New Mexico, 87301-5611

  • Site Number: USA030-1

    Glendale, California, 91206-4015

  • Site Number: USA043-1

    Greenville, North Carolina, 27834-4300

  • Site Number: USA009-1

    Hartford, Connecticut, 06112-1272

  • Site Number: USA034-1

    Hollywood, Florida, 33024-2776

  • Site Number: USA014-1

    Houston, Texas, 77054-3835

  • Site Number: USA012-1

    Houston, Texas, 77074-1802

  • Site Number: USA010-1

    Jersey City, New Jersey, 07305

  • Site Number: USA022-1

    Kansas City, Missouri, 64111-2925

  • Site Number: USA049-1

    Knoxville, Tennessee, 37924-3606

  • Site Number: USA017-1

    Las Vegas, Nevada, 89107-6100

  • Site Number: USA003-1

    Lone Tree, Colorado, 80124-3191

  • Site Number: USA039-1

    Manhasset, New York, 11030-3802

  • Site Number: USA025-1

    McAllen, Texas, 78503-1251

  • Site Number: USA006-1

    Norfolk, Virginia, 23504-2303

  • Site Number: USA028-1

    Oxford, Mississippi, 38655

  • Site Number: USA045-1

    Oxnard, California, 93036-3075

  • Site Number: USA016-1

    Pine Bluff, Arkansas, 71603-4921

  • Site Number: USA046-1

    Riverside, California, 92505-3081

  • Site Number: USA035-1

    Salinas, California, 93901-4446

  • 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: 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: USA007-1

    Shelbyville, Indiana, 46176-8591

  • Site Number: USA040-1

    Spartanburg, South Carolina, 29301-5085

  • Site Number: USA011-1

    The Bronx, New York, 10461-2755

  • Site Number: USA002-1

    The Woodlands, Texas, 77384-8042

  • Site Number: USA050-1

    Wauwatosa, Wisconsin, 53226-4339

  • Site Number: USA036-1

    Whittier, California, 90606-3007

  • Site Number: USA033-1

    Winston-Salem, North Carolina, 27103-7154

Other trials in United States

Spain6 sites

  • Site Number: ESP001-1

    Lleida, 25198

  • Site Number: ESP004-1

    Madrid, 28034

  • Site Number: ESP005-1

    Madrid, 28046

  • Site Number: ESP003-1

    Pamplona, 31008

  • Site Number: ESP006-1

    Seville, 41009

  • Site Number: ESP002-1

    Valencia, 46014

Other trials in Spain

Bulgaria4 sites

  • Site Number: BGR002-1

    Blagoevgrad, 2700

  • Site Number: BGR001-1

    Plovdiv, 4002

  • Site Number: BGR003-1

    Sofia, Sofia-Grad, 1309

  • Site Number: BGR004-1

    Sofia, Sofia-Grad, 1431

Other trials in Bulgaria

Serbia4 sites

  • Site Number: SRB001-1

    Belgrade, 11000

  • Site Number: SRB003-1

    Kragujevac, 34000

  • Site Number: SRB005-1

    Novi Sad, 21000

  • Site Number: SRB002-1

    Zaječar, 19000

Other trials in Serbia

Portugal3 sites

  • Site Number: PRT001-1

    Carregado, Lisbon District, 2580-588

  • Site Number: PRT002-1

    Forte Da Casa, Lisbon District, 2625-384

  • Site Number: PRT003-1

    Portimão, Faro District, 8500-311

Other trials in Portugal

Poland2 sites

  • Site Number: POL005-1

    Oleśnica, Lower Silesian Voivodeship, 56-400

  • Site Number: POL002-1

    Żyrardów, Masovian Voivodeship, 96-300

Other trials in Poland

About this study

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

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.

Being tested
PLS240, Placebo, Open-Label Extension PLS240
Medical subject headings
Hyperparathyroidism, Secondary, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLS240Drug

    Participants will receive intravenous (IV) PLS240 three times per week for 27 weeks.

  • PlaceboDrug

    Participants will receive intravenous (IV) placebo, containing no active drug, three times per week for 27 weeks.

  • Open-Label Extension PLS240Drug

    Participants will receive intravenous (IV) PLS240 three times per week for a maximum of 26 weeks.

Study groups in NCT05832931
Study groupRoleWhat they receive
Double-Blind Phase PLS240ExperimentalNot described
Receives: Drug: PLS240
Double-Blind Phase PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Open-Label Extension Phase PLS240ExperimentalAfter completion of the Double-Blind Phase, all participants will have the opportunity to enroll in the 26 week Open-Label extension, where they will receive PLS240.
Receives: Drug: Open-Label Extension PLS240

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: each visit from screening through week 27

  2. Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <7.5 mg/dL

    Measured: up to week 28

  3. Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <8.3 mg/dL

    Measured: up to week 28

  4. Open-Label Phase: Number of Adverse Events (AEs)

    Measured: up to week 28

  5. Open-Label Phase: Number of Serious Adverse Events (SAEs)

    Measured: up to week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start28 Apr 2023
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832931
Sponsor's protocol ID
PP3002
Other IDs
2023-504338-24, 2023
Acronym
PATH-1
Status last verified
Aug 2025
First submitted
17 Apr 2023
Last updated
9 Sep 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kendrick J, Ketteler M, Wolf M, Pesic S, Tirmenstajn-Jankovic B, Zeig S, Camp A, Copeland E, Slingsby BT, Dehmel B, Block G. Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: Two Randomized Clinical Trials. J Am Soc Nephrol. 2026 Oct 23. doi: 10.1681/ASN.0000001285. Online ahead of print.

    PubMed 42914959

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PLS240 and Open-Label Extension PLS240 in people with Secondary Hyperparathyroidism and End-stage Kidney Disease (ESKD), run by Pathalys Pharma at 68 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Spain, Bulgaria, Serbia, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Double-Blind Phase: Proportion of PLS240 treated participants compared to placebo treated participants with a ≥30% decrease in mean iPTH (time frame: each visit from screening through week 27). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832931, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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