Study Details
Testing the Study Drug Tolvaptan for Children with Autosomal Recessive Polycystic Kidney Disease
(IRB#: IRB_00150059)
Autosomal Recessive Polycystic Kidney Disease is a rare kidney disease that causes poor kidney function in children. This study will test a drug called Tolvaptan to treat children with this disease. The study wants to see if the drug helps children with this disease and is safe. Children in the study will participate in at least 11 in-person study visits at the clinic and 14 more visits have the option of home health visits. Participation lasts about 25 months. Medical tests will be done during the study to track the health of participants.
- All genders
- Under 7 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Under 7 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 28 days to less than 12 weeks old
- Diagnosis of Autosomal Recessive Polycystic Kidney Disease
- Ability for the parent/legal guardian to provide written consent
- Ability to attend in-person at the study clinic
Exclusion Criteria
- Children of premature birth less than 32 weeks before birth
- History of kidney transplantation
- Abnormal liver function
- Parents with renal cystic disease (kidneys develop sacs of fluid over time)
- Cannot monitor fluid balance
Will I be paid for my time?
Yes
IRB#: IRB_00150059
PI: Raoul Nelson
Department: PEDIATRICS
Approval Date: 2023-06-14 06:00:00
Specialties: Pediatric Nephrology