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Upacicalcet Sodium Hydrate

This article explores clinical trials investigating the use of Upacicalcet Sodium Hydrate, also known as PLS240, for treating secondary hyperparathyroidism in patients with end-stage kidney disease undergoing hemodialysis. These studies aim to assess the drug’s effectiveness in reducing parathyroid hormone levels and its overall safety profile in this patient population.

Table of Contents

What is PLS240?

PLS240 is the study name for a new medication called upacicalcet sodium hydrate. It is being developed as a potential treatment for a condition called secondary hyperparathyroidism in people with advanced kidney disease.[1]

What condition does PLS240 treat?

PLS240 is being studied to treat secondary hyperparathyroidism (SHPT) in patients with end-stage kidney disease (ESKD) who are on hemodialysis. Secondary hyperparathyroidism is a common complication in people with kidney failure. It occurs when the parathyroid glands produce too much parathyroid hormone (PTH) in response to low calcium levels in the blood.[1]

In ESKD, the kidneys can no longer effectively filter waste products from the blood or maintain proper levels of important minerals like calcium and phosphorus. This leads to mineral imbalances that cause the parathyroid glands to become overactive.

How PLS240 works

PLS240 is designed to help control PTH levels in patients with SHPT. While the exact mechanism is not fully described in the trial information, medications for SHPT typically work by mimicking calcium’s effects on the parathyroid glands. This tricks the glands into reducing PTH production.[1]

Administration and dosage

PLS240 is given as an intravenous injection three times per week after dialysis sessions. The dose is adjusted based on the patient’s PTH and calcium levels. The maximum daily dose being studied is 300 micrograms.[1]

The medication comes in pre-filled syringes called Poolsep II, which are manufactured by Nipro Corporation in Japan.[1]

Clinical trials

PLS240 is currently being studied in Phase 3 clinical trials called PATH-1 and PATH-2. These are large studies designed to evaluate how well the medication works and how safe it is in patients with SHPT who are on hemodialysis.[2]

The trials have two main parts:

  1. A double-blind phase lasting 27 weeks, where patients receive either PLS240 or a placebo
  2. An open-label extension phase, where all patients receive PLS240 for additional safety monitoring

Potential benefits

The main goals of the PLS240 clinical trials are to see if the medication can:[2]

  • Reduce PTH levels by 30% or more in patients
  • Help patients achieve PTH levels within a target range of 150-300 pg/mL
  • Improve the balance of calcium and phosphate levels in the blood

If successful, PLS240 could provide a new treatment option for managing SHPT in dialysis patients.

Safety and side effects

As PLS240 is still being studied, all of its potential side effects are not yet known. The clinical trials are closely monitoring patients for any adverse effects, including:[2]

  • Changes in blood calcium levels
  • Heart rhythm abnormalities
  • Other laboratory test changes

Patients in the trials have regular check-ups, blood tests, and ECGs to watch for any safety concerns.

Who may be eligible for PLS240 treatment?

The clinical trials for PLS240 are enrolling patients who meet specific criteria, including:[2]

  • Adults aged 18-80 years
  • Diagnosed with end-stage kidney disease and on hemodialysis for at least 3 months
  • Have high PTH levels (above 400 pg/mL) despite current treatments
  • Do not have certain other medical conditions that could interfere with the study

It’s important to note that PLS240 is still an investigational medication. It is not yet approved for general use outside of clinical trials. Patients interested in learning more should speak with their kidney specialist about current treatment options for SHPT.

Aspect Details
Drug Name Upacicalcet Sodium Hydrate (PLS240)
Condition Studied Secondary Hyperparathyroidism in End-Stage Kidney Disease patients on hemodialysis
Study Design Phase 3, Randomized, Double-Blind, Placebo-Controlled with Open-Label Extension
Primary Objective Assess efficacy in reducing iPTH by ≥30% compared to placebo
Treatment Duration 27 weeks (double-blind) + up to 6 months (open-label extension)
Dosing Three times per week after dialysis, dose titrated based on iPTH levels
Key Inclusion Criteria Age 18-80, on hemodialysis, iPTH ≥400 pg/mL, stable medication regimen
Primary Endpoint Proportion of participants with ≥30% decrease in mean iPTH during weeks 22-27
Safety Assessments Laboratory tests, ECGs, vital signs, adverse events, physical exams

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the efficacy and safety of PLS240 (Upacicalcet Sodium Hydrate) in reducing parathyroid hormone (iPTH) levels by at least 30% in patients with secondary hyperparathyroidism who are undergoing chronic hemodialysis.
  • How is PLS240 administered in these trials? PLS240 is administered as a solution for injection in pre-filled syringes. It is given three times per week after dialysis, with dose titration based on iPTH levels.
  • What are the key inclusion criteria for participants? Key inclusion criteria include being aged 18-80 years, undergoing hemodialysis three times per week for at least 3 months, having iPTH levels ≥400 pg/mL, and having stable doses of certain medications like vitamin D sterols and phosphate binders.
  • How long do the clinical trials last? The trials consist of a 27-week double-blind phase followed by an open-label extension phase. The total treatment period can last up to approximately one year for some participants.
  • What are the main outcomes being measured? The main outcomes include the proportion of participants achieving a ≥30% decrease in iPTH levels, changes in serum calcium and phosphate levels, and various safety assessments including laboratory tests, ECGs, and adverse events.

Ongoing Clinical Trials on Upacicalcet Sodium Hydrate

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Poland Portugal Spain

Glossary

  • Secondary Hyperparathyroidism (SHPT): A condition where the parathyroid glands produce excess parathyroid hormone in response to low calcium levels, often occurring in patients with kidney disease.
  • End-Stage Kidney Disease (ESKD): The final stage of chronic kidney disease where the kidneys are no longer able to function properly, requiring dialysis or kidney transplant.
  • Hemodialysis: A treatment for kidney failure that uses a machine to filter waste and excess fluids from the blood when the kidneys can no longer perform this function.
  • Parathyroid Hormone (iPTH): A hormone produced by the parathyroid glands that regulates calcium levels in the blood and bones.
  • Albumin-corrected Serum Calcium (cCa): A measurement of calcium in the blood that takes into account the level of albumin, a protein that binds to calcium.
  • Efficacy Assessment Period (EAP): The period during the clinical trial (Weeks 22-27) when the primary measurements of the drug's effectiveness are taken.
  • Double-Blind Study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Open-Label Extension: A phase of the study where all participants receive the active treatment, and both researchers and participants know what is being administered.
  • Dose Titration: The process of adjusting the dose of a medication to achieve the optimal therapeutic effect while minimizing side effects.
  • Phosphate Binders: Medications used to lower phosphate levels in the blood by binding to phosphate in the digestive tract, preventing its absorption.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-pls240-for-treating-secondary-hyperparathyroidism-in-patients-with-end-stage-kidney-disease-on-hemodialysis-2/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-pls240-for-treating-secondary-hyperparathyroidism-in-patients-with-end-stage-kidney-disease-on-hemodialysis/