Chronotherapy in Children With Chronic Kidney Disease
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 in children and adolescents with chronic kidney disease.
Conditions:
🦠 Chronic Kidney Diseases 🦠 Hypertension
🗓️ Study Start (Actual) April 2025
🗓️ Primary Completion (Estimated) February 2026
✅ Study Completion (Estimated) February 2026
👥 Enrollment (Estimated) 26
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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 Criteria:

    • * 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.
Ages Eligible for Study: 6 Years to 18 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 April 2022
  • First Submitted that Met QC Criteria 28 April 2022
  • First Posted 29 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 16 July 2024
  • Last Verified July 2024