Chronotherapy for Pediatric Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a stable dose of anti-hypertensive medication for at least 3 months. If you are currently taking diuretic medications, you cannot participate in the trial.
Is chronotherapy for pediatric chronic kidney disease safe for children?
The safety of blood pressure medications, which are often used in treating children with chronic kidney disease, is generally supported by their widespread use in managing hypertension (high blood pressure) in both children and adults. These medications, including thiazide diuretics, ACE inhibitors, and beta-blockers, are considered effective and safe for children when dosages are carefully adjusted based on weight.12345
How does the timing of blood pressure medication affect children with chronic kidney disease?
This treatment is unique because it focuses on the timing of taking blood pressure medication, known as chronotherapy, which aims to align medication administration with the body's natural rhythms to improve blood pressure control and potentially reduce kidney damage in children with chronic kidney disease.12356
What data supports the effectiveness of the drug for treating pediatric chronic kidney disease?
The research highlights that hypertension (high blood pressure) is a common issue in children with chronic kidney disease and is linked to worsening kidney function and increased cardiovascular risk. While the studies emphasize the importance of controlling blood pressure, they also indicate that current treatments, including antihypertensive drugs, are not fully effective, as many children still have uncontrolled hypertension.12357
Who Is on the Research Team?
Christine Bakhoum
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either remain on their current regimen or switch to nighttime dosing of one anti-hypertensive medication. ABPM is obtained after 1 week and at 1 month.
Washout
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.
Crossover Treatment
Participants crossover to the opposite arm and an ABPM is obtained after 1 week and at 1 month.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Current regimen
- Re-timing of anti-hypertensive drug
Re-timing of anti-hypertensive drug is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypertension
- Chronic kidney disease
- Hypertension
- Chronic kidney disease
- Heart failure
- Hypertension
- Chronic kidney disease
- Hypertension
- Chronic kidney disease
- Hypertension
- Chronic kidney disease
- Hypertension
- Chronic kidney disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
American Heart Association
Collaborator