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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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What is this study about?

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.

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.

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%.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
MHAT National Heart Hospital EAD Sofia Bulgaria
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Dkhuzb Skx zckyao Żudwgzom Zyrardow Poland
Dzcxmb Stp zjuwsn Lxjoszj Legnica Poland
Dqvcbl Soa z owuf Olesnica Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.10.2023
Poland Poland
Not recruiting
01.10.2023
Portugal Portugal
Not recruiting
01.10.2023
Spain Spain
Not recruiting
01.10.2023

Trial locations

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.

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.

Trial ID:
2023-504338-24-00
Protocol code:
PP3002
NCT ID:
NCT05832931
Trial Phase:
Therapeutic confirmatory (Phase III)

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