Study Details
Testing the Study Drug Etelcalcetide for People with Secondary Hyperparathyroidism Receiving Hemodialysis
(IRB#: IRB_00116991)
Secondary Hyperparathyroidism (HPT) is associated with loss of calcium from the bones, which can lead to bone pain and fractures, and problems with blood and heart vessels. Etelcalcetide is a study drug for people with this disease. The study will test the drug Etelcalcetide to see if it will help adults with the disease and is safe. People in the study will be randomly chosen to receive the study drug Etelcalcetide or a placebo. The placebo looks Etelcalcetide but does not have the medication. Being in the study requires attending in-person visits at the study clinic for about 32 weeks. Medical tests will be done to track the health of participants.
- All genders
- All Ages
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Ages 28 days and 17 years old; those turning 18 may stay on the study
- Diagnosis of secondary hyperparathyroidism
- Receiving hemodialysis (process to filter and clean the blood)
- Able to attend in person at the University of Utah
Exclusion Criteria
- Scheduled surgery to remove parathyroid gland (found in the neck and helps balance calcium in the blood, bone and nerve and muscle function)
- A heart problem called congenital long AT syndrome
- Certain types of cancers (but those who have had non-melanoma skin cancers, cervical, or certain types of breast cancer may still be able to participate upon study approval)
Will I be paid for my time?
Yes
IRB#: IRB_00116991
PI: Raoul Nelson
Department: PEDIATRICS
Approval Date: 2019-06-26 06:00:00
Specialties: Pediatric Nephrology