In short
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.
At a glance
- 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
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.
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.
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.
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.
The medication comes in pre-filled syringes called Poolsep II, which are manufactured by Nipro Corporation in Japan.
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.
The trials have two main parts:
- A double-blind phase lasting 27 weeks, where patients receive either PLS240 or a placebo
- 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:
- 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:
- 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:
- 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.