Study Details
Testing the Study Drug Oral Paricalcitol in Infants and Children with Chronic Kidney Disease Peritoneal Dialysis of Hemodialysis
(IRB#: IRB_00141843)
Chronic Kidney Disease Peritoneal Dialysis of Hemodialysis is a disease that can lead to kidney failure and is treated by giving fluid into the body to clean the blood. This study will test a drug called Oral Paricalcitol to treat infants and children ages 0 to 9 years old with stage 5 (patients with an average of 5 to 10 years left of life). The study drug has been approved for patients ages 10 to 16 years old. The study wants to see if the drug will help infants and children ages 0 to 9 years old with this disease and is safe. Patients in the study will be treated with Oral Paricalcitol. The drug is taken as a swallowed liquid. There are 3 ways to participate in the study. These include in-person study visits at the clinic, at home with a nurse, or over Zoom (a virtual way to attend a visit on a technology device such as a computer) with help from a nurse. Participation is about 43 weeks. Medical tests will be done to track the health of participants.
- All genders
- Under 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Under 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 0 to 9 years old
- Diagnosed with and/or being treated for Secondary hyperparathyroidism (an early issue of patients with Chronic Kidney Disease that can affect the heart)
- Diagnosed with Chronic Kidney Disease stage 5 receiving Peritoneal Dialysis or Hemodialysis for at least 30 days prior to participation
- Stable dialysate calcium content (fluid used to help clean the blood) for at least 4 weeks prior first day of participation
Exclusion Criteria
- Scheduled to receive a kidney transplant from a person who donates their live kidney within 6 months of participation or has had a kidney transplant
- Expected to stop dialysis within 3 months after participation begins
- History of an allergic reaction to paricalcitol (a vitamin taken to help patients with Chronic kidney disease on dialysis (removing excess water in the blood)
- Had a parathyroidectomy (surgery to remove part of the thyroid gland that is found in the neck and helps the body grow and develop) within 12 weeks prior to participation
- Other serious diseases that may impact participation
Will I be paid for my time?
Yes
IRB#: IRB_00141843
PI: Raoul Nelson
Department: PEDIATRICS
Approval Date: 2021-11-03 06:00:00
Specialties: Nephrology & Hypertension, Pediatric Nephrology