Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
United States412 participantsStarted 2023-05-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. 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.
What they're measuring
1
The proportion of PLS240 treated participants compared to the portion of placebo treated participants with a ≥30% decrease in mean iPTH
Timeframe: each visit from screening through week 27
2
Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <7.5 mg/dL
Timeframe: up to week 28
3
Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <8.3 mg/dL
✓. 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.
Exclusion criteria
✕. 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.
✕. 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).