A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF DOSE-TITRATED PLS240 IN THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN INDIVIDUALS WITH END STAGE KIDNEY DISEASE ON HEMODIALYSIS (PATH-1) WITH AN OPEN-LABEL EXTENSION
This research study is investigating a new medication, PLS240, for people who have end-stage kidney disease and are receiving haemodialysis. These patients often develop a condition called secondary hyperparathyroidism, where their parathyroid glands become overactive. The main goal of the study is to find out how effective PLS240 is at controlling this condition by reducing a specific hormone called iPTH. We also want to understand any potential side effects of the medication to make sure it's safe. Participants will be taking either PLS240 or a placebo (a dummy pill with no active medicine) for a period, and then everyone will have the option to take PLS240 in an open-label extension phase. The study is a Phase 3 trial, which means it's a key step in testing new treatments to ensure they are beneficial and safe for wider use.
At a glance
What is this study about?
This study is for people who have end-stage kidney disease and are on a type of treatment called haemodialysis. When your kidneys don't work properly, it can lead to another health problem called secondary hyperparathyroidism. This is when small glands in your neck, called parathyroid glands, become too active and produce too much of a hormone (iPTH), which can affect your bones and other parts of your body.
The study is testing a new medication called PLS240. The main purpose is to see if PLS240 can help to lower the levels of this specific hormone (iPTH) in your blood, and by how much. We also want to make sure that the medication is safe to take and that any side effects are mild and manageable. If PLS240 is found to be both effective and safe, it could become a new treatment option for people like you.
This is a 'Phase 3' study, which is an important stage in testing new medicines. It means that the drug has already been tested in smaller groups of people, and now we are comparing it to a 'placebo' (a dummy pill that looks like the real thing but contains no active medicine) to get clear results. This helps us confirm if the benefits are really due to the medication itself. After the main comparison part, there's often a chance for all participants to receive the active medication in an 'open-label extension', meaning everyone knows they are getting PLS240.
Key takeaways
- New study for people with end-stage kidney disease on dialysis.
- Investigating a medication called PLS240 for secondary hyperparathyroidism.
- Compares PLS240 to a placebo (dummy pill) first, then offers active drug to all.
- Aims to reduce specific hormone levels (iPTH) and check for safety.
- Regular health checks, blood tests, and medical monitoring are part of the process.
- Participation is voluntary, with potential benefits and risks explained.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. To be considered, you must have end-stage kidney disease and be receiving regular haemodialysis treatment. You also need to have a history of secondary hyperparathyroidism, which is the condition this new medication aims to treat.
There will be other detailed health checks to make sure this study is right for you and safe. For example, the researchers will check your current blood test results, review your medical history, and look at any other medications you might be taking. These steps are standard for all clinical trials to ensure everyone's safety and to gather accurate results.
- Are you 18 years old or older?
- Do you have end-stage kidney disease?
- Are you currently receiving haemodialysis treatments?
- Have you been diagnosed with secondary hyperparathyroidism?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly chosen to receive either the new medication, PLS240, or a placebo (a dummy pill) for a certain period. This is called a 'double-blind' study, meaning neither you nor your study doctor will know which one you're taking. After this initial period, there will be an option for you to continue in an 'open-label' phase, where all participants receive PLS240, and everyone will know they are taking the active drug.
Throughout the study, you'll have regular visits to the clinic for various checks. These will include blood tests to measure your hormone levels (like iPTH and calcium), checks of your vital signs (such as blood pressure and heart rate), ECGs (heart tracings), and physical examinations. The doctors will also carefully monitor any side effects you might experience. The medication will be taken as prescribed, and the dosage may be adjusted during the study based on your individual needs. We don't have the exact total duration listed, but these types of studies typically involve several months of active participation with ongoing follow-up.
Potential risks and benefits
Locations (4)
- —Poland
- —Portugal
- —Spain
- —Bulgaria
Common questions
What is 'secondary hyperparathyroidism'?
It's a condition where your parathyroid glands make too much hormone because your kidneys aren't working well, often seen in people with advanced kidney disease.
What is PLS240?
PLS240 is a new medication being tested in this study to help control secondary hyperparathyroidism in people with end-stage kidney disease.
What does 'double-blind, placebo-controlled' mean?
It means some people get the new drug, and others get a dummy pill (placebo). Neither you nor your doctor will know which one you're on, to make the results fair and unbiased.
Will I have to pay to join the study?
No, you should not have to pay to participate in a clinical trial. All study-related medication and assessments are usually covered by the study sponsor.
Can I leave the study at any time?
Yes, your participation is completely voluntary. You can choose to leave the study at any point, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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