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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and month 1

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Interventional procedure

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

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 / 2Eligibility criteria met

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Who is running the clinical trial?

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,415 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,566 Total Patients Enrolled

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,600 Total Patients Enrolled

Media Library

Re-timing of anti-hypertensive drug (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05353335 — N/A

High Blood Pressure Research Study Groups: remain on their current regimen, nighttime dosing of one anti-hypertensive medication

High Blood Pressure Clinical Trial 2023: Re-timing of anti-hypertensive drug Highlights & Side Effects. Trial Name: NCT05353335 — N/A

Re-timing of anti-hypertensive drug (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05353335 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for volunteers to participate in this research?

"As per the information posted on clinicaltrials.gov, this medical trial has ceased actively seeking patients for enrollment. The study was initially initiated on December 1st 2022 and last edited on April 28th 2022 - however, there are an abundance of alternate studies that are currently recruiting participants."

Answered by AI

Is the age cutoff for this trial restricted to those under 70?

"This clinical trial requires all applicants to be between the ages of 6 and 18. There are 95 studies aimed at younger patients, and 1,091 dedicated to those 65 years or older."

Answered by AI

Is there an opportunity to participate in this clinical experiment?

"The research team is seeking 26 juveniles aged 6 to 18 with hypertension for this study. To qualify, participants must be male or female, have Chronic Kidney Disease (CKD), an estimated glomerular filtration rate of 30-90 ml/min/1.73 m2 and the necessary anti-hypertensive medication in their system for at least 3 months prior to enrolment. Additionally, they should demonstrate non-dipping on Ambulatory Blood Pressure Monitoring (ABPM)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chronotherapy in Children With Chronic Kidney Disease

2024. "Chronotherapy in Children With Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05353335.

All > Chronic Kidney Disease