Peptide
Etelcalcetide (Parsabiv)
Etelcalcetide is a synthetic D-amino acid peptide calcimimetic approved for secondary hyperparathyroidism (SHPT) in hemodialysis patients. FDA-approved in 2017, it is the first IV calcimimetic. Phase III trials showed 74-75% of patients achieved >30% PTH reduction vs 8-10% placebo. Administered via IV injection at end of hemodialysis 3x/week.
- Updated
- How we grade
- 43 studies cited
Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.
- Best evidence
- Grade A
- Conditions studied
- 1
- Outcomes
- 9
- Graded outcomes
- 4311
Evidence by condition
- Strong
- Moderate
- Limited
- Very limited
General
Key findings
- Serum CalciumImproves (the measure goes down)
- Serum PhosphorusImproves (the measure goes down)
- PTH ReductionImproves (the measure goes down)
Safety notes in the studies
- Effective reduction in serum calcium levels, though hypocalcemia-related adverse events require monitoring and dose adjustment.
Studies cited
43 studies from PubMed
- Adverse events reporting of Etelcalcetide: a real-word analysis from FAERS database.
- Real-world safety profile of etelcalcetide in dialysis-related secondary hyperparathyroidism: a pharmacovigilance analysis of FAERS data.
- The calcium-sensing receptor: a comprehensive review on its role in calcium homeostasis and therapeutic implications.
- Calcimimetics treatment strategy for serum calcium and phosphate management in patients with secondary hyperparathyroidism undergoing dialysis: A systematic review and meta-analysis of randomized studies.
- Effects of active vitamin D analogs and calcimimetic agents on PTH and bone mineral biomarkers in hemodialysis patients with SHPT: a network meta-analysis.
- Effect of etelcalcetide versus alfacalcidol on left ventricular function and feature-tracking cardiac magnetic resonance imaging in hemodialysis-a post-hoc analysis of a randomized, controlled trial.
- Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease-Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients.
- Cardio-renal interaction - Clinical trials update 2022.
- Phase 1, single-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of etelcalcetide in pediatric patients with secondary hyperparathyroidism receiving hemodialysis.
- Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52 weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan.
- A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis.
- Randomized Trial of Etelcalcetide for Cardiac Hypertrophy in Hemodialysis.
- Comparative Effects of Etelcalcetide and Maxacalcitol on Serum Calcification Propensity in Secondary Hyperparathyroidism: A Randomized Clinical Trial.
- A Prospective, Randomized Clinical Trial of Etelcalcetide in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism (the DUET Trial)
- [Long-term efficacy and safety of etelcalcetide in hemodialysis patients with severe secondary hyperparathyroidism].
- New scenarios in secondary hyperparathyroidism: etelcalcetide. Position paper of working group on CKD-MBD of the Italian Society of Nephrology.
- Recent advances in understanding and managing secondary hyperparathyroidism in chronic kidney disease.
- Comparative Effectiveness of Calcimimetic Agents for Secondary Hyperparathyroidism in Adults: A Systematic Review and Network Meta-analysis.
- Etelcalcetide versus placebo for secondary hyperparathyroidism in patients receiving hemodialysis: A meta-analysis of randomized controlled trials.
- An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism
- One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism
- Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in "Real Life"
- Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective.
- Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR-HD).
- Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
- Managing hyperparathyroidism in hemodialysis: role of etelcalcetide
- Etelcalcetide (Parsabiv) for Secondary Hyperparathyroidism
- Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis.
- [New scenarios in secondary hyperparathyroidism: etelcalcetide. Position paper of Nephrologists form Lombardy].
- Etelcalcetide (Parsabiv) for Secondary Hyperparathyroidism in Adults With Chronic Kidney Disease on Hemodialysis.
- Etelcalcetide for Treating Secondary Hyperparathyroidism: An Evidence Review Group Evaluation of a NICE Single Technology Appraisal.
- Role of etelcalcetide in the management of secondary hyperparathyroidism in hemodialysis patients: a review on current data and place in therapy.
- Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials
- Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial
- Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism
- Etelcalcetide for the treatment of secondary hyperparathyroidism
- A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese haemodialysis patients.
- Pharmacokinetics, Biotransformation, and Excretion of [(14)C]Etelcalcetide (AMG 416) Following a Single Microtracer Intravenous Dose in Patients with Chronic Kidney Disease on Hemodialysis.
- Drug disposition model of radiolabeled etelcalcetide in patients with chronic kidney disease and secondary hyperparathyroidism on hemodialysis.
- Etelcalcetide, A Novel Calcimimetic, Prevents Vascular Calcification in A Rat Model of Renal Insufficiency with Secondary Hyperparathyroidism.
- Formulary Drug Review: Etelcalcetide.
- Etelcalcetide: First Global Approval
- Nonclinical Safety Profile of Etelcalcetide, a Novel Peptide Calcimimetic for the Treatment of Secondary Hyperparathyroidism.