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Chronotherapy for Pediatric Chronic Kidney Disease

N/A

Recruiting

Led By Christine Bakhoum

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

History of organ transplantation, oncological disease, or dialysis

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 1

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if taking one blood pressure medication at night, instead of in the morning, can improve normal blood pressure patterns in children and adolescents with chronic kidney disease.

Who is the study for?

This trial is for children and adolescents up to 18 years old with chronic kidney disease (CKD) and high blood pressure, who have been on a stable dose of anti-hypertensive medication for at least three months. They must show abnormal blood pressure patterns overnight and have an eGFR between 30-90 ml/min/1.73 m2. Kids under six or those unable to complete necessary tests, on diuretics, with a history of organ transplant, cancer, or dialysis are excluded.

What is being tested?

The study is testing if changing the time when one anti-hypertensive drug is taken from morning to evening can help normalize blood pressure during sleep in kids with CKD. It's a pilot crossover trial meaning each participant will receive both treatments in sequence over different periods.

What are the potential side effects?

Since the intervention involves re-timing existing medications rather than introducing new ones, side effects may not change significantly but could include typical reactions to anti-hypertensive drugs such as dizziness, headache, fatigue or stomach issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 18 and have chronic kidney disease.

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My kidney function, measured by eGFR, is between 30 to 90 ml/min/1.73 m2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant, cancer, or been on dialysis.

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I am older than 6 years.

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I am currently taking water pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and month 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and month 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Interventional procedure

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: nighttime dosing of one anti-hypertensive medicationExperimental Treatment1 Intervention

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.

Group II: remain on their current regimenActive Control1 Intervention

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.

0 / 5Eligibility criteria met