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Study on the Effectiveness and Safety of PLS240 for Treating Secondary Hyperparathyroidism in Patients with End-Stage Kidney Disease on Hemodialysis

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Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of secondary hyperparathyroidism in individuals with end stage kidney disease who are undergoing hemodialysis. The treatment being tested is a medication called PLS240, which contains the active substance upacicalcet sodium hydrate. The study aims to evaluate how well PLS240 works in reducing a hormone called parathyroid hormone (PTH) in the blood and to assess its safety over time.

The study is divided into two phases. In the first phase, participants will receive either PLS240 or a placebo to compare the effects. This phase is designed to see if PLS240 can effectively lower PTH levels by at least 30%. In the second phase, which is open-label, all participants will receive PLS240 to further assess its long-term safety. Participants will receive the medication through an intravenous injection, which means it will be administered directly into a vein using a pre-filled syringe.

The trial will last for a maximum of 53 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. These check-ups will include laboratory tests, physical exams, and monitoring of vital signs. The goal is to ensure the treatment is both effective and safe for individuals with secondary hyperparathyroidism undergoing hemodialysis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's purpose and procedures. Written consent is required to confirm understanding and agreement to participate.
Step 2
Double-blind phase
During this phase, the participant will receive either the investigational medication PLS240 or a placebo. The medication is administered as a solution for injection using a pre-filled syringe.
The administration route is through an intravenous bolus injection or IV infusion. The dosage and frequency will be determined by the study protocol, focusing on reducing the levels of a hormone called iPTH by at least 30%.
Step 3
Efficacy assessment period
This period occurs between weeks 22 and 27 of the study. The participant's response to the treatment is evaluated by measuring the change in iPTH levels compared to baseline values.
Step 4
Safety follow-up
After completing the double-blind phase, a safety follow-up visit is conducted. This includes clinical laboratory tests, vital signs monitoring, ECGs, and physical exams to ensure the participant's well-being.
Step 5
Open-label extension phase
Participants who complete the double-blind phase may enter the open-label extension phase. In this phase, all participants receive PLS240 to assess its long-term safety.
The same administration method is used, and regular monitoring continues to ensure safety and effectiveness.

Who can join the trial?

16 criteria

Must be between 18 and 80 years old at the time of giving consent to participate.
Must have a pre-dialysis blood test showing **iPTH** (a hormone related to parathyroid function) levels of at least 400 pg/mL on two separate occasions, at least one week apart, during the screening period.
Must voluntarily provide written consent to participate in the study.
Must agree not to participate in another study involving experimental treatments during this study.
For the Open-Label Extension Phase, must have completed the treatment and final safety follow-up of the Double-Blind Phase.
Must provide written consent to participate in the Open-Label Extension Phase.
Must be undergoing **hemodialysis** (a treatment for kidney failure) three times a week.
Must have been on hemodialysis for at least three months and have a **Kt/V** (a measure of dialysis effectiveness) of at least 1.2 within four weeks before signing the consent form.
Must have a pre-dialysis blood test showing **iPTH** levels of at least 450 pg/mL on two separate occasions, at least one week apart, during the screening period. Only one repeat test is allowed, and it must be done at least a week after the previous test.
Must have a pre-dialysis blood test showing **cCa** (calcium levels) of at least 8.3 mg/dL during the screening period. This can be tested up to three times during the screening period.
Must have a **dialysate calcium concentration** (calcium level in the dialysis fluid) of at least 2.5 mEq/L, stable for at least four weeks before signing the consent form.
If taking active Vitamin D sterols (like doxercalciferol or calcitriol) for managing SHPT, the dose must be stable (no more than 50% change) for two months before signing the consent form and expected to remain stable during the study.
If taking phosphate binders, the dose must be stable (no more than 50% change) for two months before signing the consent form and expected to remain stable during the study.
If taking calcium supplements, the dose must be stable (no more than 50% change) for two months before signing the consent form and expected to remain stable during the study.
Female participants must be post-menopausal (no periods for the past year and over 50 years old), surgically sterilized, have a medical condition preventing pregnancy, commit to abstinence, or use highly effective contraception during the study and for two weeks after the last dose. Women of child-bearing potential must have a negative pregnancy test during the screening period.
Male participants must agree to use highly effective contraception when sexually active and not donate sperm during the treatment phase and for two weeks after the last dose.

Who cannot join the trial?

3 criteria

Participants who are not currently undergoing maintenance hemodialysis. This is a treatment that uses a machine to clean the blood when the kidneys are not working properly.
Participants without a history of secondary hyperparathyroidism (SHPT). This is a condition where the parathyroid glands in the neck produce too much hormone due to another disease, often related to kidney problems.
Participants who have not completed the safety follow-up visit of the Double-Blind Phase of the study.

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Verified & featured
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Not recruiting
Verified
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Lleida, Spain
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

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Investigated drugs

PLS240 is a medication being studied for its ability to treat secondary hyperparathyroidism in people with end-stage kidney disease who are on hemodialysis. The trial aims to see if PLS240 can effectively reduce the levels of a hormone called iPTH by at least 30%. The study also includes a phase where participants who have completed the initial part of the trial will continue to take PLS240 to evaluate its long-term safety.

Upacicalcet Sodium Hydrate

What is already known about the treatment

PLS240 – PLS240 is administered orally and is currently being evaluated in clinical trials for its effectiveness and safety in treating secondary hyperparathyroidism in patients with end-stage kidney disease undergoing hemodialysis. The medication is in the Phase 3 stage of clinical trials, which means it is being tested for efficacy and safety in a larger group of participants. The main therapeutic indication for PLS240 is to reduce elevated levels of parathyroid hormone in these patients. At the molecular level, PLS240 works by modulating the activity of the parathyroid gland, thereby decreasing the production of parathyroid hormone. It is classified pharmacologically as a calcimimetic agent, which means it mimics the action of calcium on tissues, particularly the parathyroid gland, to help regulate calcium and phosphorus levels in the body.

Investigated diseases

Secondary Hyperparathyroidism – This condition occurs when the parathyroid glands produce too much parathyroid hormone (PTH) due to another underlying issue, often related to chronic kidney disease. It is commonly seen in individuals undergoing maintenance hemodialysis, as their kidneys are unable to maintain the balance of minerals and nutrients in the blood. Over time, this can lead to an increase in PTH levels, which may cause bone pain and fragility, as well as cardiovascular issues. The disease progresses as the kidneys continue to fail, leading to further imbalances in calcium and phosphorus levels. This can result in calcification of blood vessels and other tissues, contributing to additional health complications.