New drug aims to tame parathyroid glands in dialysis patients

NCT ID NCT05836220

Disease control Sponsor: Pathalys Pharma Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called PLS240 in 412 adults with end-stage kidney disease on dialysis who also have overactive parathyroid glands (secondary hyperparathyroidism). Participants received either PLS240 or a placebo intravenously three times a week for 27 weeks, followed by an open-label phase where all could receive PLS240. The main goal was to see if PLS240 could lower parathyroid hormone levels by at least 30%.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: PLS240 (a drug given intravenously three times a week)
What this could lead to: If successful, PLS240 could offer a new treatment option to better control secondary hyperparathyroidism in people on dialysis, potentially reducing complications.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The drug requires frequent IV dosing, and side effects or limited effectiveness compared to existing treatments remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

May 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 - 80 years at time of informed consent. 2. 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. 3. 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. 4. 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. 5. Dialysate calcium concentration ≥2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to signing the ICF. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. Voluntarily given written informed consent to participate in this study. 12. 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: 13. Have successfully completed the course of treatment and final safety follow-up visit of the Double-Blind Phase. 14. Voluntarily given written informed consent to participate in the Open-Label Extension Phase of the study. 15. Prescribed hemodialysis for 3 times per week. 16. Continue to meet Inclusion Criteria 9, 10, and 12. Exclusion Criteria: 1. Diagnosis of primary hyperparathyroidism. 2. 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. 3. History of parathyroid intervention including parathyroidectomy (PTx) and percutaneous ethanol injection therapy (PEIT) within 26 weeks before signing the ICF. 4. Treatment with any prohibited medication as defined in Section 8.3.1. 5. Anticipated or scheduled parathyroidectomy during the study period. 6. Planned living-related or living-unrelated kidney transplant during the study period. 7. 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. 8. 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). 9. Clinically significant abnormalities on screening laboratory tests (may repeat abnormal laboratory tests) according to the Investigator including but not limited to the following: 1. Serum albumin ≤3.0 g/dL 2. Serum magnesium \<1.5 mg/dL 3. Serum P \>8.0 mg/dL 4. Hemoglobin \<8.5 g/dL 5. Platelet count \<100,000 x106/L 6. 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. 10. 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. 11. 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). 12. 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. 13. History of New York Heart Association (NYHA) Functional Class 3 or 4 heart failure. 14. History of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 4 months prior to signing the ICF. 15. Stroke (cerebral infarction or cerebral hemorrhage) within 6 months prior to signing the ICF. 16. Participant is receiving treatment for a seizure disorder or has a history of a seizure within 12 weeks prior to signing the ICF. 17. Poorly controlled diabetes mellitus, in the judgment of the investigator or sub-investigator. 18. 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. 19. 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). 20. History of symptomatic ventricular dysrhythmias or Torsade de Pointes. 21. History of or family history of long QT syndrome. 22. QTcF \>500 msec on screening ECG. 23. Pregnant or breast feeding. 24. Prior exposure or hypersensitivity to PLS240 or any of its components. 25. Current, recent, or suspected infection with SARS-CoV-2/COVID-19 within 4 weeks prior to signing the ICF. 26. 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: 27. In the opinion of the investigator, continuation into the Open-Label Extension Phase is not considered safe and/or feasible. 28. Continues to meet Exclusion Criterion #5.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage kidney disease Secondary hyperparathyroidism

Contacts and locations

Locations

Site Number: BGR001-2

Gabrovo, 5300, Bulgaria
Site Number: BGR002-2

Rousse, 7002, Bulgaria
Site Number: BGR003-2

Lom, Montana, 3600, Bulgaria
Site Number: BGR004-2

Varna, 9000, Bulgaria
Site Number: ESP003-2

Córdoba, Cordoba, 14004, Spain
Site Number: ESP005-2

Manises, Valencia, 46940, Spain
Site Number: POL001-2

Lodz, Lódzkie, 90-242, Poland
Site Number: POL002-2

Poznan, Greater Poland Voivodeship, 60-214, Poland
Site Number: POL004-2

Tomaszów Mazowiecki, Lódzkie, 97-200, Poland
Site Number: POL005-2

Warsaw, Masovian Voivodeship, 02-758, Poland
Site Number: PRT001-2

Carnaxide, 2790-134, Portugal
Site Number: PRT002-2

Covilha, Castelo Branco District, 6200-000, Portugal
Site Number: PRT003-2

Lisbon, 1250-203, Portugal
Site Number: SRB001-2

Kruševac, 37000, Serbia
Site Number: SRB002-2

Niš, 18000, Serbia
Site Number: SRB003-2

Belgrade, 11000, Serbia
Site Number: SRB004-2

Užice, 31000, Serbia
Site Number: SRB005-2

Belgrade, Belgrade, 11080, Serbia
Site Number: USA001-2

Chula Vista, California, 91910-3813, United States
Site Number: USA002-2

Hollywood, Florida, 33024-2776, United States
Site Number: USA003-2

San Diego, California, 92111-3636, United States
Site Number: USA004-2

Fort Myers, Florida, 33908-4154, United States
Site Number: USA005-2

La Mesa, California, 91942-3017, United States
Site Number: USA006-2

Waxahachie, Texas, 75165-1399, United States
Site Number: USA007-2

Amherst, New York, 14228-2792, United States
Site Number: USA008-2

San Antonio, Texas, 78251-4125, United States
Site Number: USA009-2

Toledo, Ohio, 43606-1171, United States
Site Number: USA010-2

Greenville, South Carolina, 29605-4019, United States
Site Number: USA011-2

El Paso, Texas, 79925-4828, United States
Site Number: USA012-2

San Antonio, Texas, 78221-3019, United States
Site Number: USA013-2

Columbus, Georgia, 31904-3603, United States
Site Number: USA015-2

Newark, Delaware, 19713-2081, United States
Site Number: USA016-2

Minneapolis, Minnesota, 55404-1212, United States
Site Number: USA017-2

Middlebury, Connecticut, 06762-2843, United States
Site Number: USA018-2

San Dimas, California, 91773-3539, United States
Site Number: USA019-2

Granada Hills, California, 91344-7407, United States
Site Number: USA020-2

Escondido, California, 92025-4402, United States
Site Number: USA021-2

Tarzana, California, 91356-3647, United States
Site Number: USA022-2

Moorpark, California, 93021-3352, United States
Site Number: USA023-2

Arvada, Colorado, 80002-3714, United States
Site Number: USA024-2

Wichita, Kansas, 67214-2944, United States
Site Number: USA025-2

Kalamazoo, Michigan, 49007-3889, United States
Site Number: USA026-2

Durham, North Carolina, 27704-2147, United States
Site Number: USA027-2

Knoxville, Tennessee, 37923-3624, United States
Site Number: USA028-2

Mishawaka, Indiana, 46545-3519, United States
Site Number: USA029-2

Live Oak, Texas, 78233-4767, United States
Site Number: USA030-2

Los Angeles, California, 90022-4302, United States
Site Number: USA031-2

Aurora, Colorado, 80045-7202, United States
Site Number: USA033-2

Northridge, California, 91324-3528, United States
Site Number: USA034-2

Fullerton, California, 92832-3037, United States
Site Number: USA035-2

South Miami, Florida, 33143-5522, United States
Site Number: USA037-2

Norfolk, Virginia, 23507-1901, United States
Site Number: USA038-2

St. George, Utah, 84790-5898, United States
Site Number: USA039-2

Anaheim, California, 92801-6731, United States
Site Number: USA041-2

Orlando, Florida, 32801, United States
Site Number: USA042-2

Fresno, California, 93720-3389, United States
Site Number: USA043-2

Los Angeles, California, 90033, United States
Site Number: USA044-2

Lancaster, California, 93534-2831, United States
Site Number: USA045-2

Roseburg, Oregon, 97471-6214, United States
Site Number: USA046-2

Glendale, California, 91205-3313, United States
Site Number: USA048-2

Detroit, Michigan, 48236-2169, United States
Site Number: USA049-2

Northridge, California, 91324-2927, United States
Site Number: USA051-2

Fairfax, Virginia, 22033-1907, United States
Site Number: USA052-2

Victorville, California, 92395-8322, United States
Site Number: USA053-2

Charlotte, North Carolina, 28208-3876, United States
Site Number: USA054-2

New Orleans, Louisiana, 70112, United States
Site Number: USA055-2

Prosper, Texas, 75078-1411, United States
Site Number: USA056-2

Tarzana, California, 91356-2806, United States

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