Status:
WITHDRAWN
Chronotherapy in Children With Chronic Kidney Disease
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Heart Association
Conditions:
Chronic Kidney Diseases
Hypertension
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
This is a pilot, crossover trial in which the investigator will determine if retiming of one anti-hypertensive medication from morning to evening can effectuate normal blood pressure dipping patterns ...
Detailed Description
Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, ran...
Eligibility Criteria
Inclusion
- Male or female child/adolescent up to 18 years of age with CKD
- estimated glomerular filtration rate (eGFR) of 30 to 90 ml/min/1.73 m2
- diagnosed with hypertension and on a stable dose of anti-hypertensive medication(s) for at least 3 months
- Non-dipping identified on ABPM
Exclusion
- history of organ transplantation, oncological disease, or dialysis
- inability to complete 24-hour ABPM or 24-hour urine collection
- Children less than 6 years of age will be excluded, as they often are unable to complete a successful ABPM study (≥ 40 readings, with 1 reading per hour of sleep)
- Currently on diuretic medications.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05353335
Start Date
April 1 2025
End Date
February 1 2026
Last Update
June 13 2025
Active Locations (1)
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1
Yale New Haven Children's Hospital/Yale New Haven Health
New Haven, Connecticut, United States, 06520