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Calcimimetic Agent
PLS240 for Secondary Hyperparathyroidism (PATH-1 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
Participants receiving calcium supplements must be on a stable dose within the 2 months prior to signing the ICF and remain stable through the screening period
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 28
Awards & highlights
PATH-1 Trial Summary
This trial studies the safety and effectiveness of PLS240 to treat kidney disease and high levels of calcium caused by the disease. Patients will receive PLS240 or placebo and attend multiple study visits for exams, blood tests and ECGs.
Who is the study for?
Adults aged 18-80 on hemodialysis for end-stage kidney disease with secondary hyperparathyroidism can join. They must have stable vitamin D, phosphate binder, and calcium supplement doses, agree to contraception if applicable, and not be in other studies. Excluded are those with primary hyperparathyroidism, recent heart issues or strokes, uncontrolled diabetes or hypertension, certain ECG abnormalities, recent serious infections like COVID-19, or a history of malignancy within the last two years.Check my eligibility
What is being tested?
The trial tests PLS240's effectiveness and safety against placebo in patients undergoing hemodialysis due to severe kidney disease complicated by secondary hyperparathyroidism. It has a double-blind phase (27 weeks) followed by an open-label extension (26 weeks), where all receive PLS240. Participants will undergo regular blood tests, ECGs and physical exams.See study design
What are the potential side effects?
While specific side effects of PLS240 aren't listed here, common ones may include reactions at the injection site such as pain or swelling; nausea; fatigue; bone pain due to changes in parathyroid hormone levels; itching related to high phosphorus levels; muscle weakness or cramps.
PATH-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been taking the same dose of calcium supplements for the last 2 months.
Select...
I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.
Select...
I am between 18 and 80 years old.
PATH-1 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
Double-Blind Phase: Proportion of PLS240 treated participants compared to placebo treated participants with a ≥30% decrease in mean iPTH
Open-Label Phase: Number of Adverse Events (AEs)
Open-Label Phase: Number of Serious Adverse Events (SAEs)
+2 morePATH-1 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?
Pathalys PharmaLead Sponsor
1 Previous Clinical Trials
375 Total Patients Enrolled
Launch TherapeuticsUNKNOWN
1 Previous Clinical Trials
375 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have important irregularities in your screening blood tests, as determined by the doctor in charge of the study.I have not had a stroke in the last 6 months.I am being treated for seizures or had a seizure in the last 3 months.My diabetes is not well-managed according to my doctor.I have been taking the same dose of calcium supplements for the last 2 months.I or someone in my family has long QT syndrome.Your heart's electrical activity is too slow, which can be seen in a test called an ECG.I haven't had COVID-19 in the last 4 weeks.I have been on a steady dose of phosphate binders for the last 2 months.I am a woman not at risk of becoming pregnant or will use effective birth control during and after the study.I am scheduled for or expecting to have parathyroid surgery soon.I have had cancer within the last 2 years.My blood pressure was high during two or more dialysis sessions in the last two weeks.I am a man willing to use effective birth control and not donate sperm during and for 2 weeks after treatment.You have had an allergic reaction to PLS240 or any of its parts before.I am scheduled for a kidney transplant from a living donor during the study.I have had a parathyroid procedure within the last 6 months.I am not taking any medications that are not allowed in the study.I have been diagnosed with primary hyperparathyroidism.My parathyroid hormone levels were above 1500 pg/mL on two or more tests.I have had heart rhythm problems or Torsade de Pointes.I have had a heart attack or heart surgery in the last 4 months.I haven't changed my dialysis type, calcium levels, or treatment time in the last 4 weeks.I have not missed more than 2 dialysis sessions in the last 8 weeks without a valid reason.You had severe chest pain at rest or with minimal activity in the past 8 weeks, unless a heart doctor says it's okay for you to join the study.I have had severe heart failure in the past.If the doctor thinks it's not safe for you to continue in the study, or if your iPTH levels are too high, you can't join the next part of the study.I've been on a stable dose of Vitamin D for SHPT for the last 2 months.My parathyroid hormone levels are high, confirmed by two tests a week apart.My calcium levels were 8.3 mg/dL or higher during the screening period.Your dialysis solution has a high calcium level and has been stable for at least 4 weeks before starting the study.I am between 18 and 80 years old.I have been on hemodialysis 3 times a week for over 3 months with adequate dialysis efficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Double-Blind Phase PLS240
- Group 2: Double-Blind Phase Placebo
- 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.
Secondary Hyperparathyroidism Patient Testimony for trial: Trial Name: NCT05832931 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the elderly population within the parameters of eligibility for this research project?
"To be eligible for inclusion in this clinical trial, patients must have a minimum age of 18 and not exceed 80 years old."
Answered by AI
Is enrolment currently available for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants since being posted on April 28th 2023 and most recently updated June 2nd of the same year. A total 375 volunteers are needed for 3 trial locations."
Answered by AI
Has the Double-Blind Phase PLS240 been sanctioned by the FDA?
"After careful consideration, our team has assigned a rating of 3 out of 3 to the safety profile of Double-Blind Phase PLS240. This is due to multiple rounds of clinical data that supports efficacy and a lack of evidence pointing towards any adverse effects."
Answered by AI
May I participate in this experiment?
"This clinical trial is recruiting 375 individuals with secondary hyperparathyroidism that are aged 18 years to 80 years old."
Answered by AI
How many participants are enrolled in the trial presently?
"Affirmative. According to the records on clinicaltrials.gov, this research study is currently looking for suitable participants and was initially posted on April 28th 2023. With a last update made on June 2nd of the same year, 375 subjects are required across 3 centres."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Illinois
What site did they apply to?
Site Number: USA007-1
Site Number: USA014-1
Site Number: USA023-1
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have CKD stage 3 and non-alcoholic fatty liver with stage 2 scarring. I want to try to be as healthy as possible, and need to learn as much as possible.
PatientReceived no prior treatments
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