Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-04-18
Brief Title:
Parathyroid Hormone PTH Attenuation Trial in Hemodialysis-2
Sponsor:
Pathalys Pharma
Organization:
Pathalys Pharma
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATH-2
Brief 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504339-41 | EUDRACT_NUMBER | None | None |