Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-1
United States, Bulgaria, Poland362 participantsStarted 2023-04-28
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a drug called PLS240 specifically for secondary hyperparathyroidism in people on hemodialysis — do you think my PTH levels and kidney disease stage are similar enough to the participants in this study that the results might be relevant to my situation?
2The main goal of the double-blind phase was to see if PLS240 could lower iPTH levels by at least 30% — given my current iPTH numbers, is a 30% reduction a meaningful target for me, and how does that compare to what my current treatment is achieving?
3The open-label phase tracked low calcium levels, including seriously low thresholds like below 7.5 mg/dL — is low calcium already a concern for me given my kidney disease, and how would that risk factor into any decision about a treatment like this?
4Since this was a Phase 3 trial that has now completed, does that mean there's enough safety and effectiveness data available for you to evaluate PLS240 as a potential option, or would I need to wait for published results before it could be considered?
5Are there existing approved treatments for secondary hyperparathyroidism in hemodialysis patients — like cinacalcet or other calcimimetics — that I should try first, or is there a reason a newer approach like the one studied in this trial might be worth discussing for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Double-Blind Phase: Proportion of PLS240 treated participants compared to 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
Timeframe: up to week 28
4
Open-Label Phase: Number of Adverse Events (AEs)
Timeframe: up to week 28
5
Open-Label Phase: Number of Serious Adverse Events (SAEs)
. 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.
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).