What side effects are associated with this type of intervention?

Common treatments for secondary hyperparathyroidism (SHPT) that modulate parathyroid gland activity, such as calcimimetics and vitamin D analogs, have notable side effects. Calcimimetics, like cinacalcet, can cause nausea, vomiting, and hypocalcemia. Vitamin D analogs, such as calcitriol, may lead to hypercalcemia and hyperphosphatemia. These treatments necessitate careful monitoring of calcium and phosphate levels to prevent adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Secondary Hyperparathyroidism (SHPT) that modulate parathyroid gland activity to control PTH secretion. Notable among these are calcimimetics like cinacalcet, which increases the sensitivity of calcium-sensing receptors on the parathyroid gland, thereby reducing PTH levels. Another drug, etelcalcetide, is an intravenous calcimimetic used in patients undergoing hemodialysis. These treatments aim to manage PTH levels effectively, similar to the investigational drug PLS240 being studied for its efficacy and safety in patients with hemodialysis-dependent end-stage kidney disease and SHPT.

What other types of research exist?

Promising novel alternatives to PLS240 for secondary hyperparathyroidism in 2024 include: 1) Etelcalcetide, a calcimimetic agent that activates calcium-sensing receptors on parathyroid glands, reducing PTH secretion. 2) Evocalcet, another calcimimetic with a similar mechanism but potentially fewer side effects. 3) Extended-release formulations of existing calcimimetics like cinacalcet, which may improve patient compliance and outcomes. These alternatives are supported by clinical trials and ongoing research.

← Back to Search

Calcimimetic Agent

PLS240 for Secondary Hyperparathyroidism (PATH-1 Trial)

Phase 3

Waitlist Available

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

Must not have

Participant is receiving treatment for a seizure disorder or has a history of a seizure within 12 weeks prior to signing the ICF

History of or family history of long QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each visit from screening through week 27

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called PLS240 to help people with severe kidney disease who are on dialysis and have a related gland problem. The study will check if PLS240 can safely manage their condition by controlling certain hormones and minerals in their blood. Patients will be monitored over time.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am being treated for seizures or had a seizure in the last 3 months.

Select...

I or someone in my family has long QT syndrome.

Select...

I am scheduled for or expecting to have parathyroid surgery soon.

Select...

My blood pressure was high during two or more dialysis sessions in the last two weeks.

Select...

I am scheduled for a kidney transplant from a living donor during the study.

Select...

I am not taking any medications that are not allowed in the study.

Select...

I have been diagnosed with primary hyperparathyroidism.

Select...

I have had heart rhythm problems or Torsade de Pointes.

Select...

I have had severe heart failure in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each visit from screening through week 27

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each visit from screening through week 27

This trial's timeline: 3 weeks for screening, Varies for treatment, and each visit from screening through week 27 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Double-Blind Phase: Proportion of PLS240 treated participants compared to placebo treated participants with a ≥30% decrease in mean iPTH

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Secondary Hyperparathyroidism (SHPT) include calcimimetics, vitamin D analogs, and phosphate binders. Calcimimetics, such as cinacalcet, work by increasing the sensitivity of the calcium-sensing receptors on the parathyroid gland, thereby reducing parathyroid hormone (PTH) secretion. Vitamin D analogs help to suppress PTH production by promoting calcium absorption in the gut and directly acting on the parathyroid glands. Phosphate binders reduce serum phosphate levels, which indirectly lowers PTH secretion. These treatments are crucial for SHPT patients as they help manage elevated PTH levels, thereby preventing complications such as bone pain, fractures, and cardiovascular issues.