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Calcimimetic Agent
PLS240 for Secondary Hyperparathyroidism (PATH-2 Trial)
Phase 3
Recruiting
Research Sponsored by Pathalys Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants who are willing to use highly effective contraception when sexually active and will not donate sperm during the treatment phase and for 2 weeks after the last dose of IP
Prescribed hemodialysis for 3 times per week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 28
Awards & highlights
PATH-2 Trial Summary
This trial evaluates the safety and effectiveness of a new drug for people with kidney failure and high levels of calcium in the blood. Patients get the drug or a placebo over two phases, then have exams and tests throughout.
Who is the study for?
Adults aged 18-80 on hemodialysis for end-stage kidney disease with secondary hyperparathyroidism can join. They must have specific levels of parathyroid hormone and calcium, stable doses of certain medications, and agree to contraception if applicable. Excluded are those with primary hyperparathyroidism, recent heart issues or seizures, certain cancers within the last two years, uncontrolled diabetes or hypertension, and anyone who's been in other drug trials recently.Check my eligibility
What is being tested?
The trial tests PLS240's effectiveness and safety against a placebo in patients undergoing hemodialysis due to severe kidney disease causing high parathyroid hormone levels. It has two phases: a double-blind phase where participants get either PLS240 or placebo randomly for 27 weeks; followed by an open-label extension where all receive PLS240 for another 26 weeks.See study design
What are the potential side effects?
While the side effects of PLS240 aren't specified here, similar drugs may cause issues like nausea, dizziness, bone pain or fractures due to changes in calcium levels. There could also be reactions at injection sites and potential impacts on blood pressure.
PATH-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.
Select...
I am on hemodialysis 3 times a week.
Select...
I am between 18 and 80 years old.
Select...
I have finished all treatments and safety checks from the earlier blind study phase.
PATH-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Open-Label Phase: Number of AE's
Open-Label Phase: Number of SAE's
Open-Label Phase: Proportion of participants with a corrected serum calcium (cCa) <7.5 mg/dL
+2 morePATH-2 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Extension Phase PLS240Experimental Treatment1 Intervention
After completion of the Double-Blind Phase, all participants will have the opportunity to enroll in the 26 week Open-Label extension, where they will receive PLS240.
Group II: Double-Blind Phase PLS240Experimental Treatment1 Intervention
Group III: Double-Blind Phase PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Launch TherapeuticsUNKNOWN
1 Previous Clinical Trials
375 Total Patients Enrolled
Pathalys PharmaLead Sponsor
1 Previous Clinical Trials
375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I or my family have a history of long QT syndrome.I am scheduled for a kidney transplant from a living donor during the study.My blood pressure has been very high during dialysis sessions.I am a woman who cannot become pregnant or will avoid pregnancy during the study.I have not missed more than 2 dialysis sessions in the last 8 weeks without a valid reason.Your blood test shows low levels of albumin.Your serum phosphate level is higher than 8.0 mg/dL.I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.I am on hemodialysis 3 times a week.I haven't changed my dialysis type or settings in the last 4 weeks.I have had heart rhythm problems or Torsade de Pointes.I am between 18 and 80 years old.I have had a heart attack or heart surgery in the last 4 months.I haven't had COVID-19 in the last 4 weeks.Your iPTH level is higher than 1500 pg/mL at the final assessment and follow-up visit.My calcium levels were 8.3 mg/dL or higher during the screening period.I have been taking a consistent dose of calcium supplements for the last 2 months.I have been on a stable dose of Vitamin D medication for SHPT for the last 2 months.Your heart takes too long to recharge between beats, as shown on a heart test.I have been diagnosed with primary hyperparathyroidism.My parathyroid hormone levels were above 1500 pg/mL at least twice before dialysis.I have had treatment for my parathyroid within the last 6 months.Your hemoglobin level is less than 8.5 grams per deciliter.Your platelet count is less than 100,000 per microliter.Your liver enzymes are more than 2.5 times the normal level.You have recently experienced severe chest pain at rest or with minimal activity, or chest pain while on dialysis, unless a heart doctor has confirmed that it is not related to heart problems.Your diabetes is not well controlled, according to the doctor.I haven't had cancer, except for some skin or cervical types, in the last 2 years.I am being treated for seizures or had a seizure in the last 3 months.You have had an allergic reaction to PLS240 or any of its parts before.I have finished all treatments and safety checks from the earlier blind study phase.My iPTH levels were 400 pg/mL or higher on two different tests.I have been on a stable dose of phosphate binders for the last 2 months.You have a specific level of calcium in your dialysis fluid that has been stable for at least 4 weeks before joining the study.Your lab tests show important health problems that need to be checked again by the doctor.Your blood magnesium level is less than 1.5 mg/dL.I am scheduled for or might have a parathyroid gland surgery.I have severe heart failure.I have not had a stroke in the last 6 months.I have been on hemodialysis 3 times a week for over 3 months with a Kt/V of at least 1.2 recently.
Research Study Groups:
This trial has the following groups:- Group 1: Double-Blind Phase Placebo
- Group 2: Double-Blind Phase PLS240
- Group 3: Open-Label Extension Phase PLS240
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this clinical research limited by age?
"The patient selection criteria for this clinical trial restricts enrollment to those aged 18 and over, but below the age of 80."
Answered by AI
Is PLS240 approved by the FDA for Open-Label Extension Phase clinical trials?
"Our team at Power has assigned a safety rating of 3 to Open-Label Extension Phase PLS240, as it is an advanced phase 3 trial. This signifies that there exists evidence for the efficacy and security of this medication."
Answered by AI
How many individuals are currently being accepted to participate in this clinical trial?
"This study necessitates 375 patients that fulfil the requisite criteria. Pathalys Pharma is sponsoring and executing this trial in Fort Myers, Florida (USA004-2) as well as Minneapolis, Minnesota (USA016-2)."
Answered by AI
What are the qualifications for joining this research trial?
"For admittance into the trial, candidates must satisfy two criteria: have secondary hyperparathyroidism and be between 18 to 80 years old. Up to 375 individuals are being recruited for this medical study."
Answered by AI
Are any more participants being sought for this trial at the moment?
"Affirmative. The clinical trial database lists this study as actively recruiting participants, which was initially posted on May 15th 2023 and edited most recently on June 2nd 2023. This medical research is seeking 375 volunteers from 5 distinct locations to participate."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Site Number: USA017-2
What portion of applicants met pre-screening criteria?
Did not meet criteria
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