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NCT05836220: PATH-2
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
Phase 3 trial testing PLS240 in Secondary Hyperparathyroidism in 412 participants. Completed in 5 August 2025.
5 August 2025
Quick facts
| Lead sponsor | Pathalys Pharma |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 412 |
| Start date | 15 May 2023 |
| Primary completion | 5 August 2025 |
| Estimated completion | 5 August 2025 |
| Sites | 68 locations across Serbia, Poland, Bulgaria, Portugal, United States, Spain |
Drugs / interventions tested
- PLS240 — full drug profile →
- Placebo
- Open-Label Extension PLS240 — full drug profile →
Conditions studied
- Secondary Hyperparathyroidism — all drugs for Secondary Hyperparathyroidism →
- End Stage Kidney Disease — all drugs for End Stage Kidney Disease →
Sponsor
Pathalys Pharma — full company profile →
Who can join
Adults 18 to 80, any sex, with Secondary Hyperparathyroidism or End Stage Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05836220
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PLS240
Trials testing the same drug.
- NCT05832931 — Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1 · Phase 3 · completed
Other recruiting trials for Secondary Hyperparathyroidism
Currently open trials in the same condition.
- NCT06130683 — Single-Cell Sequence Technology Used to Reveal Heterogeneity of Secondary Hyperparathyroidism · active not recruiting
- NCT05880914 — Precision Medicine Approaches to Renal Osteodystrophy · recruiting
- NCT03969329 — A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis · Phase 3 · recruiting
- NCT03633708 — A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemo · Phase 3 · recruiting
Other Pathalys Pharma trials
Trials by the same sponsor.
- NCT05832931 — Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1 · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05836220 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pathalys Pharma
- Last refreshed: 9 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05836220.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing