Ongoing Clinical Trials for Secondary Hyperparathyroidism
Secondary hyperparathyroidism is a condition where the parathyroid glands produce too much parathyroid hormone, often occurring in people with kidney disease or after weight loss surgery. Currently, there are 3 ongoing clinical trials testing treatments for this condition. These studies are taking place in the Netherlands, Portugal, Bulgaria, Poland, and Spain, and are investigating medications including alfacalcidol and PLS240.
Clinical trial locations
- Bulgaria
- Netherlands
- Poland
- Portugal
- Spain
Study of alfacalcidol for treating secondary hyperparathyroidism in patients after gastric bypass surgery
This trial focuses on testing alfacalcidol, a form of active vitamin D, for treating patients who develop excessive parathyroid hormone levels after undergoing Roux-en-Y gastric bypass surgery.
Who can participate: Adults aged 18 to 65 years who have had gastric bypass surgery and subsequently developed the condition are eligible. Participants must have adequate vitamin D levels (above 50 nmol/l) and be taking only standard supplements following their surgery. Both men and women can participate, including women who have gone through menopause. Participants need to be able to provide written consent.
Who cannot participate: The study excludes people younger than 18 or older than 65, pregnant or breastfeeding women, and those planning pregnancy during the study. People with allergies to alfacalcidol, severe kidney disease, liver disease, or a history of primary hyperparathyroidism cannot join. Those taking medications that might interact with alfacalcidol, people with active cancer, uncontrolled high blood calcium, kidney stones, substance abuse issues, or mental conditions affecting consent are also excluded. Participation in another trial within the last 30 days is not allowed.
What the trial involves: The study aims to determine if alfacalcidol can help normalize hormone levels in people who develop this condition after weight loss surgery. Participants will take the medication orally once daily for 24 months. The medication comes in soft capsules of different strengths (0.25, 0.5, or 1 microgram). Throughout the study, doctors will monitor hormone levels and bone health using blood tests and special bone density scans of the spine, hip, and arm bones. Participants will also complete quality of life questionnaires every six months to track how the treatment affects their daily lives.
Investigational drug: Alfacalcidol is a form of active vitamin D that helps control parathyroid hormone levels. It works by helping the body maintain proper calcium balance and bone health, which can be affected after weight loss surgery. This medication is particularly effective because it is activated in the liver and doesn’t require kidney activation like natural vitamin D.
Study on the Effectiveness and Safety of PLS240 for Treating Secondary Hyperparathyroidism in Patients with End Stage Kidney Disease on Hemodialysis
This trial is evaluating PLS240, a medication designed to reduce elevated parathyroid hormone levels in people with end-stage kidney disease who are undergoing regular hemodialysis treatments.
Who can participate: Adults aged 18 to 80 years who have been receiving hemodialysis three times weekly for at least three months are eligible. Participants must have elevated levels of intact parathyroid hormone (iPTH) of at least 400 pg/mL measured on two separate occasions at least one week apart. Their corrected calcium level must be at least 8.3 mg/dL, and the calcium level in their dialysis fluid must be at least 2.5 mEq/L and stable for at least four weeks. If taking active vitamin D medications, phosphate binders, or calcium supplements, doses must be stable for at least two months before starting and expected to remain stable during the study. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control, as must male participants. Written consent is required.
Who cannot participate: The study excludes individuals not undergoing maintenance hemodialysis and those without a history of secondary hyperparathyroidism. For the open-label extension phase, participants who have not completed the safety follow-up visit of the initial phase cannot participate.
What the trial involves: The study is divided into two phases lasting up to 53 weeks total. In the first phase, which is double-blind, participants receive either PLS240 or a placebo through an intravenous injection using a pre-filled syringe. This phase aims to determine if PLS240 can effectively lower parathyroid hormone levels by at least 30% compared to placebo. The key assessment period occurs between weeks 22 and 27. In the second phase, which is open-label, all participants receive PLS240 to assess its long-term safety. Throughout the study, participants have regular check-ups including laboratory tests, vital signs monitoring, physical exams, and ECGs to monitor their health and treatment effects.
Investigational drug: PLS240 contains upacicalcet sodium hydrate and is classified as a calcimimetic agent. This means it mimics the action of calcium on tissues, particularly the parathyroid gland, helping to regulate calcium and phosphorus metabolism in the body and thereby reducing parathyroid hormone production.
Study on the Effectiveness and Safety of PLS240 for Treating Secondary Hyperparathyroidism in Patients with End-Stage Kidney Disease on Hemodialysis
This trial is testing PLS240 as a treatment for patients with end-stage kidney disease on hemodialysis who have developed excessive parathyroid hormone production.
Who can participate: Adults aged 18 to 80 years who have been on hemodialysis three times weekly for at least three months with a dialysis effectiveness measure (Kt/V) of at least 1.2 are eligible. Participants must have iPTH levels of at least 450 pg/mL measured on two separate occasions at least one week apart, with only one repeat test allowed. Their corrected calcium level must be at least 8.3 mg/dL, which can be tested up to three times during screening. The dialysate calcium concentration must be at least 2.5 mEq/L and stable for four weeks before enrollment. If taking active vitamin D medications, phosphate binders, or calcium supplements for managing the condition, doses must have been stable (no more than 50% change) for two months before enrollment and are expected to remain stable. Women must be post-menopausal, surgically sterilized, have a medical condition preventing pregnancy, or use highly effective contraception, with a negative pregnancy test required for women of childbearing potential. Male participants must also agree to use contraception and not donate sperm during treatment and for two weeks after the last dose.
Who cannot participate: People not currently undergoing maintenance hemodialysis or those without a history of secondary hyperparathyroidism cannot participate. For the open-label extension phase, participants who have not completed the safety follow-up visit of the initial double-blind phase are excluded.
What the trial involves: The study lasts up to 53 weeks and consists of two phases. During the double-blind phase, participants receive either PLS240 or a placebo through an intravenous injection or infusion. The goal is to reduce iPTH levels by at least 30%. The efficacy assessment period occurs between weeks 22 and 27. After completing the double-blind phase, participants undergo a safety follow-up visit that includes clinical laboratory tests, vital signs monitoring, ECGs, and physical exams. Those who complete the initial phase may enter the open-label extension phase, where all participants receive PLS240 to assess its long-term safety using the same administration method with regular monitoring.
Investigational drug: PLS240 contains upacicalcet sodium hydrate and works as a calcimimetic agent. It modulates the activity of the parathyroid gland by mimicking calcium’s action on tissues, thereby decreasing parathyroid hormone production and helping to regulate calcium and phosphorus levels in the body.
Summary
There are currently three ongoing clinical trials for secondary hyperparathyroidism, addressing two distinct patient populations. One trial focuses on patients who have undergone gastric bypass surgery and is taking place in the Netherlands, testing alfacalcidol as a treatment. The other two trials are targeting patients with end-stage kidney disease on hemodialysis and are being conducted across multiple countries including Portugal, Bulgaria, Poland, and Spain. These two trials are testing the same medication, PLS240, which is in Phase 3 of clinical development.
The trials reflect the different causes of secondary hyperparathyroidism, with one addressing the condition following bariatric surgery and two focusing on kidney disease-related cases. The geographic concentration of trials in Southern and Eastern Europe for the hemodialysis population suggests these regions may have significant patient populations or research infrastructure for kidney disease studies. Both medications being tested work through different mechanisms – alfacalcidol as an active vitamin D analog and PLS240 as a calcimimetic agent – offering potentially complementary approaches to managing this condition in different patient groups.
