Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Launched by KAI PHARMACEUTICALS · Jun 1, 2010
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects provides written informed consent.
- • Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and \< 1200 pg/ml for Cohorts 1-3).
- • Serum corrected calcium ≥ 9.0 mg/dL
- • Receiving hemodialysis three times per week for at least 3 months and had adequate hemodialysis with a delivered Kt/V (dialyzer clearance of urea \* dialysis time/ volume of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)
- • ≥ 65%.
- • Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests
- Exclusion Criteria:
- • History or symptomatic ventricular dysrhythmias
- • History of angina pectoris or congestive heart failure
- • History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
- • History of or treatment for seizure disorder
- • Recent (3 months) parathyroidectomy
About Kai Pharmaceuticals
Kai Pharmaceuticals is a biopharmaceutical company focused on developing innovative therapies for patients with serious medical conditions. With a strong emphasis on precision medicine, Kai leverages cutting-edge research and technology to create targeted treatments that address unmet medical needs. The company is committed to advancing its clinical pipeline through rigorous scientific investigation and collaboration with healthcare professionals, ensuring that their therapies are not only effective but also safe for patient use. Driven by a core mission to improve patient outcomes, Kai Pharmaceuticals is dedicated to transforming the landscape of therapeutic options in its therapeutic areas of focus.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Shreveport, Louisiana, United States
Shreveport, Louisiana, United States
Brisbane, Queensland, Australia
Cypress, California, United States
Melbourne, Victoria, Australia
Patients applied
Trial Officials
Gregory Bell, MD
Study Director
KAI Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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