Study Details
Testing the Drug Tolvaptan for Infants and Children with Autosomal Recessive Polycystic Kidney Disease
(IRB#: IRB_00161351)
Autosomal Recessive Polycystic Kidney Disease is a rare kidney disease that causes poor kidney function in infants and children. This study will test a drug called Tolvaptan to treat infants and children with this disease. The study wants to see if the drug helps infants and children with this disease and is safe. Infants and children in the study will participate in at least 11 in-person study visits at the clinic and 9 more visits have the option of home health visits. Participation lasts about 19 months. Medical tests will be done during the study to track the health of participants.
- All genders
- All Ages
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: All Ages
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 28 days to less than 18 years old at time of enrollment
- Diagnosis of Autosomal Recessive Polycystic Kidney Disease
- Ability for the parent or legal guardian to provide written consent
- Ability to attend in person at the study clinic
Exclusion Criteria
- Participants of premature birth less than 32 weeks before birth for infants 28 days and less than 12 weeks old
- History of kidney transplantation
- Conditions of renal cysts (kidneys develop sacs of fluid) other than Autosomal Recessive Polycystic Kidney Disease
- Abnormal liver function
- Parents with renal cystic disease (kidneys develop sacs of fluid)
Will I be paid for my time?
Yes
IRB#: IRB_00161351
PI: Raoul Nelson
Department: PEDIATRICS
Approval Date: 2023-07-19 06:00:00
Specialties: Pediatric Nephrology