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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

Fast replyInvestigationalNo placebo

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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 effectiveness and safety of a treatment called PLS240 for individuals with secondary hyperparathyroidism, a condition that often occurs in people with end-stage kidney disease who are on hemodialysis. Secondary hyperparathyroidism is a disorder where the parathyroid glands in the neck produce too much hormone due to low calcium levels, often seen in patients with kidney disease. The treatment being tested, PLS240, is a solution for injection that contains the active substance upacicalcet sodium hydrate.

The purpose of this study is to evaluate how well PLS240 works in reducing the levels of a hormone called iPTH (intact parathyroid hormone) by at least 30% in participants undergoing regular hemodialysis. The study is divided into two phases: a double-blind phase, where neither the participants nor the researchers know who is receiving PLS240 or a placebo, and an open-label phase, where all participants receive PLS240. The double-blind phase will help determine the effectiveness of PLS240 compared to a placebo, while the open-label phase will focus on the long-term safety of the treatment.

Participants in the study will receive PLS240 through an intravenous bolus injection or IV infusion, which means the medication is delivered directly into the bloodstream. The study will last for a maximum of 53 weeks, during which participants will be closely monitored for changes in their iPTH levels and any potential side effects. The study aims to provide valuable information on the potential benefits and safety of PLS240 for managing secondary hyperparathyroidism in patients with end-stage kidney disease on 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 objectives and procedures. Consent is required to proceed.
Step 2
Double-blind phase
During this phase, participants will receive either the investigational drug PLS240 or a placebo. The drug 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 frequency and dosage will be determined by the study protocol.
The main goal is to evaluate the effectiveness of PLS240 in reducing parathyroid hormone levels by at least 30% in individuals with secondary hyperparathyroidism undergoing hemodialysis.
Step 3
Efficacy assessment period
This period occurs between weeks 22 and 27 of the double-blind phase. The primary focus is on measuring the decrease in parathyroid hormone levels compared to baseline values.
Step 4
Safety follow-up
Participants will undergo safety assessments, including laboratory tests, vital signs monitoring, and physical exams. This ensures the safety of the investigational drug.
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 focus is on monitoring any changes in calcium levels and other safety parameters.

Who can join the trial?

16 criteria

Must be between 18 and 80 years old.
Must be receiving hemodialysis treatment three times a week for at least three months.
Must have a specific blood test result called **iPTH** (intact parathyroid hormone) of at least 400 pg/mL on two separate occasions, at least one week apart, before starting the study.
Must have a **cCa** (corrected calcium) level of at least 8.3 mg/dL in a blood test before starting the study.
The calcium level in the dialysis fluid must be at least 2.5 mEq/L and stable for at least four weeks before starting the study.
If taking active Vitamin D medications, the dose must be stable for at least two months before starting the study and expected to remain stable during the study.
If taking phosphate binders, the dose must be stable for at least two months before starting the study and expected to remain stable during the study.
If taking calcium supplements, the dose must be stable for at least two months before starting the study.
Female participants must be post-menopausal, surgically sterilized, unable to become pregnant, or agree to use effective birth control during the study and for two weeks after the last dose. Women who can become pregnant must have a negative pregnancy test before starting the study.
Male participants must agree to use effective birth control when sexually active and not donate sperm during the study and for two weeks after the last dose.
Must voluntarily agree to participate in the study by signing a consent form.
Must agree not to participate in another study involving experimental treatments during this study.
To join the Open-Label Extension Phase, must have completed the initial treatment and follow-up visits of the Double-Blind Phase.
Must voluntarily agree to participate in the Open-Label Extension Phase by signing a consent form.
Must continue to receive hemodialysis treatment three times a week.
Must continue to meet the criteria related to birth control and consent as mentioned above.

Who cannot join the trial?

3 criteria

Participants who are not 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 sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD
Varna, Bulgaria
Responsive
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Carnaxide, Portugal

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Investigated drugs

PLS240 is a medication being studied for its ability to reduce high levels of parathyroid hormone in people with secondary hyperparathyroidism who are on hemodialysis due to end-stage kidney disease. The trial aims to see if PLS240 can effectively lower these hormone levels by at least 30% compared to not receiving the medication. Additionally, the study will look at the long-term safety of PLS240 for those who continue using it after the initial trial phase.

Upacicalcet Sodium Hydrate

What is already known about the treatment

PLS240 – PLS240 is an investigational medication administered orally, designed to treat secondary hyperparathyroidism in patients with end-stage kidney disease undergoing hemodialysis. Currently, it is in Phase 3 clinical trials, where its efficacy and safety are being evaluated. The main therapeutic indication is to reduce elevated levels of parathyroid hormone, which is common in these patients. 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, helping to regulate calcium and phosphorus metabolism in the body.

Investigated diseases

End-Stage Kidney Disease (ESKD)
This condition occurs when the kidneys are no longer able to function at a level needed for day-to-day life. It is the final stage of chronic kidney disease, where the kidneys have lost about 85-90% of their function. Patients with ESKD often require dialysis or a kidney transplant to survive. The disease progresses as kidney function continues to decline, leading to the accumulation of waste products and fluid in the body. Symptoms may include fatigue, swelling, and difficulty concentrating. Management focuses on slowing progression and managing symptoms.
Secondary Hyperparathyroidism (SHPT)
This condition is characterized by an overproduction of parathyroid hormone (PTH) due to chronic kidney disease. It occurs when the kidneys fail to maintain proper levels of calcium and phosphorus in the blood, leading to increased PTH production. SHPT can result in bone pain, fractures, and cardiovascular issues. The disease progresses as kidney function declines, causing further imbalances in calcium and phosphorus. Patients may experience symptoms related to bone and mineral disorders. Management aims to control PTH levels and maintain mineral balance.