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Etelcalcetide

Etelcalcetide, also known as AMG 416 or Parsabiv, is a drug being studied in clinical trials for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease who are on hemodialysis. These trials aim to evaluate the safety, efficacy, and long-term effects of etelcalcetide in managing parathyroid hormone levels and mineral metabolism in both adult and pediatric patients.

Table of Contents

What is Etelcalcetide?

Etelcalcetide is a medication used to treat a condition called secondary hyperparathyroidism in patients with chronic kidney disease who are on hemodialysis. It is also known by its brand name Parsabiv™ and was previously referred to as AMG 416 or KAI-4169 during its development[1][3]. This drug is designed to help control the levels of certain minerals in your body, which can become imbalanced when your kidneys are not functioning properly.

What Conditions Does Etelcalcetide Treat?

Etelcalcetide is primarily used to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are receiving hemodialysis[1]. Let’s break down these terms:

  • Secondary Hyperparathyroidism (SHPT): This is a condition where the parathyroid glands produce too much parathyroid hormone (PTH). It often occurs as a result of chronic kidney disease.
  • Chronic Kidney Disease (CKD): This is a long-term condition where the kidneys don’t work as well as they should. When kidneys are damaged, they can’t properly regulate minerals in the body, leading to SHPT.
  • Hemodialysis: This is a treatment for kidney failure where a machine filters waste and excess fluids from your blood, performing the job that healthy kidneys would normally do.

Etelcalcetide is specifically used in patients with CKD who are on hemodialysis and have developed SHPT as a complication[2]. It helps manage the mineral and bone disorder associated with CKD, which can lead to serious complications if left untreated.

How Does Etelcalcetide Work?

Etelcalcetide works by mimicking the action of calcium in your body. It’s known as a calcimimetic, which means it binds to and activates the calcium-sensing receptors in the parathyroid glands[3]. Here’s how it helps:

  • It tricks the parathyroid glands into thinking there’s more calcium in the blood than there actually is.
  • This causes the glands to reduce their production of parathyroid hormone (PTH).
  • By lowering PTH levels, it helps to control the balance of calcium and phosphorus in your body.
  • This can help prevent complications like bone disease and the buildup of calcium in blood vessels and other tissues.

By controlling these mineral levels, etelcalcetide helps to manage the symptoms and potential complications of secondary hyperparathyroidism in CKD patients[4].

How is Etelcalcetide Administered?

Etelcalcetide is given in a unique way compared to many other medications:

  • It is administered as an intravenous (IV) injection.
  • The injection is given at the end of each hemodialysis session, typically three times per week.
  • It’s injected into the venous line of the dialysis circuit, which means it goes directly into your bloodstream[1].
  • The starting dose is usually 5 mg, but this can be adjusted by your doctor based on your response to the treatment[10].
  • The maximum dose is typically 15 mg three times per week[2].

Your healthcare provider will determine the right dose for you based on your PTH and calcium levels. They will monitor these levels regularly and adjust your dose as needed[9].

Effectiveness of Etelcalcetide

Clinical trials have shown that etelcalcetide is effective in treating secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. Here are some key findings:

  • Many patients experience a significant reduction in PTH levels after starting treatment with etelcalcetide[10].
  • In one study, a high percentage of patients achieved at least a 30% reduction in PTH levels from baseline[8].
  • Etelcalcetide has been shown to help control not only PTH levels, but also calcium and phosphorus levels in the blood[9].
  • The effects of etelcalcetide appear to be maintained over long-term treatment, with studies following patients for up to 52 weeks[10].

It’s important to note that individual responses to the medication can vary. Your healthcare provider will monitor your progress closely to ensure the treatment is working effectively for you.

Potential Side Effects

Like all medications, etelcalcetide can cause side effects. Some of the most common side effects reported in clinical trials include:

  • Decreased calcium levels (hypocalcemia): This is one of the most important side effects to be aware of. Your doctor will monitor your calcium levels closely[3].
  • Muscle spasms
  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Low blood pressure

In some cases, more serious side effects can occur. These may include severe hypocalcemia, worsening heart failure, or allergic reactions. It’s crucial to report any unusual symptoms to your healthcare provider immediately[5].

Use in Special Populations

While etelcalcetide is primarily used in adult patients, research is ongoing to understand its use in special populations:

  • Pediatric Patients: Clinical trials are being conducted to evaluate the safety and effectiveness of etelcalcetide in children and adolescents with CKD on hemodialysis[6][7].
  • Elderly Patients: The medication has been studied in older adults, but as with any medication, dosing may need to be adjusted based on individual factors.
  • Patients with Liver Problems: No dose adjustment is typically needed for patients with mild to moderate liver impairment, but caution is advised in patients with severe liver disease.

Always inform your healthcare provider about all your medical conditions and medications to ensure etelcalcetide is safe and appropriate for you.

Ongoing Research

Researchers continue to study etelcalcetide to better understand its long-term effects and potential benefits. Some areas of ongoing research include:

  • The impact of etelcalcetide on bone health and the risk of fractures in CKD patients[4].
  • Its effect on vascular calcification (the buildup of calcium in blood vessels)[4].
  • The use of etelcalcetide in pediatric patients with SHPT[8].
  • Long-term safety and efficacy studies to understand the effects of the medication over extended periods[10].

These ongoing studies will help healthcare providers better understand how to use etelcalcetide most effectively and safely in different patient populations.

Aspect Details
Drug Name Etelcalcetide (also known as AMG 416, KAI-4169, Parsabiv)
Primary Use Treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis
Administration Intravenous injection, typically three times a week at the end of hemodialysis sessions
Main Outcomes Studied Changes in PTH levels, serum calcium and phosphorus levels, safety profile, long-term efficacy
Patient Populations Adults and children (ages 2-18) with SHPT receiving hemodialysis
Potential Benefits Improved control of PTH, calcium, and phosphorus levels; potential improvements in bone health and cardiovascular outcomes
Common Side Effects Hypocalcemia, muscle spasms, diarrhea, nausea, vomiting
Ongoing Research Long-term safety and efficacy, pediatric dosing and effects, impact on bone and vascular health

FAQ

  • What is etelcalcetide used for? Etelcalcetide is used to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease who are on hemodialysis. It helps control parathyroid hormone (PTH) levels and manage mineral metabolism disorders associated with kidney disease.
  • How is etelcalcetide administered? Etelcalcetide is administered as an intravenous (IV) injection, typically given three times a week at the end of each hemodialysis session. The dose may be adjusted based on the patient's response and lab results.
  • What are the main outcomes being studied in etelcalcetide clinical trials? The main outcomes include changes in PTH levels, serum calcium and phosphorus levels, safety profile, and long-term efficacy. Some trials also look at bone health, cardiovascular effects, and quality of life measures.
  • Are there any clinical trials studying etelcalcetide in children? Yes, there are clinical trials evaluating the safety and efficacy of etelcalcetide in pediatric patients aged 2 to 18 years with SHPT who are receiving hemodialysis. These studies aim to determine appropriate dosing and assess the drug's effects in younger patients.
  • What are the potential side effects of etelcalcetide? Common side effects observed in clinical trials include decreased calcium levels (hypocalcemia), muscle spasms, diarrhea, nausea, and vomiting. The trials closely monitor for these and other adverse events to ensure patient safety.

Ongoing Clinical Trials on Etelcalcetide

  • Phase 3 Evaluation of Etelcalcetide for Secondary Hyperparathyroidism in Pediatric Patients with Chronic Kidney Disease on Hemodialysis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Germany Greece Italy Poland +2

Glossary

  • Secondary Hyperparathyroidism (SHPT): A condition where the parathyroid glands produce too much parathyroid hormone (PTH) in response to low calcium levels, often occurring in patients with chronic kidney disease.
  • Parathyroid Hormone (PTH): A hormone produced by the parathyroid glands that regulates calcium, phosphate, and vitamin D levels in the blood and bones.
  • Hemodialysis: A treatment for kidney failure that uses a machine to filter waste, excess fluids, and electrolytes from the blood when the kidneys can no longer perform this function adequately.
  • Chronic Kidney Disease (CKD): A condition characterized by gradual loss of kidney function over time, often leading to complications such as mineral and bone disorders.
  • Mineral and Bone Disorder (MBD): A common complication of chronic kidney disease that affects bone metabolism and can lead to bone fragility, deformities, and vascular calcification.
  • Calcimimetic: A type of drug that mimics the action of calcium on certain receptors, used to treat secondary hyperparathyroidism by reducing PTH secretion.
  • Hypocalcemia: A condition characterized by low levels of calcium in the blood, which can cause symptoms such as muscle spasms and weakness.
  • Phosphorus: A mineral that works with calcium to build strong bones and teeth. In kidney disease, phosphorus levels can become too high and need to be controlled.
  • Efficacy Assessment Period (EAP): A specific timeframe during a clinical trial when the effectiveness of the treatment is evaluated, typically towards the end of the study period.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and relationship between drug concentration and effect.

References

  1. https://clinicaltrials.gov/study/NCT01576146
  2. https://clinicaltrials.gov/study/NCT03795558
  3. https://clinicaltrials.gov/study/NCT01932970
  4. https://clinicaltrials.gov/study/NCT03960437
  5. https://clinicaltrials.gov/study/NCT02102204
  6. https://clinicaltrials.gov/study/NCT02833857
  7. https://clinicaltrials.eu/trial/phase-3-evaluation-of-etelcalcetide-for-secondary-hyperparathyroidism-in-pediatric-patients-with-chronic-kidney-disease-on-hemodialysis/
  8. https://clinicaltrials.gov/study/NCT03633708
  9. https://clinicaltrials.gov/study/NCT01414114
  10. https://clinicaltrials.gov/study/NCT01785875