Chronotherapy in Children With Chronic Kidney Disease

NCT05353335 | Withdrawn DMC

• 2 other identifiers: 20000315751K23DK129836-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 in children and adolescents with chronic kidney disease.

Conditions

Chronic Kidney Diseases; Hypertension

Outcome Measures

Primary Outcomes (1)

• Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).

  Percent change in systolic nocturnal blood pressure will be calculated as : (daytime mean SBP - nighttime mean SBP)/daytime mean SBP x 100 to assess if nocturnal BP dipping can be restored.

  Baseline and Month 1

Secondary Outcomes (2)

• Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.

  Baseline and Month 1

• Change in proportion of participants with restoration of dipping while on the intervention, defined as <10% systolic or diastolic nocturnal blood pressure change

  Baseline and Month 1

Study Arms (2)

nighttime dosing of one anti-hypertensive medication

EXPERIMENTAL

13 participants will be randomized to nighttime dosing of one anti-hypertensive medication. After 1 week, a repeat ABPM will be obtained. At 1 month from randomization, another ABPM will be obtained. Following this, there will be a 2-week washout period, during which all subjects will be on their usual anti-hypertensive regimen. A repeat ABPM will be obtained after the washout period. Next, the subjects will crossover to the opposite arm and an ABPM will be obtained after 1 week. A final ABPM will be obtained at 1 month after crossover.

Other: Re-timing of anti-hypertensive drug

remain on their current regimen

ACTIVE COMPARATOR

13 participants will be randomized to remain on their current regimen. After 1 week, a repeat ABPM will be obtained. At 1 month from randomization, another ABPM will be obtained. Following this, there will be a 2-week washout period, during which all subjects will be on their usual anti-hypertensive regimen. A repeat ABPM will be obtained after the washout period. Next, the subjects will crossover to the opposite arm and an ABPM will be obtained after 1 week. A final ABPM will be obtained at 1 month after crossover.

Other: Current regimen

Interventions

Re-timing of anti-hypertensive drug OTHER

The intervention will consist of shifting the anti-hypertensive medication from morning/early dose to an evening/later dose

nighttime dosing of one anti-hypertensive medication

Current regimen OTHER

The participants will begin on their current regimen.

remain on their current regimen

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• American Heart Association: collaborator

Study Sites (1)

Yale New Haven Children's Hospital/Yale New Haven Health

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christine Bakhoum

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: April 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)