Chronotherapy for Pediatric Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether taking blood pressure medication at night, rather than in the morning, can better manage blood pressure in children and teens with chronic kidney disease. It targets those on a stable dose of blood pressure medication for at least three months and diagnosed with high blood pressure that does not decrease at night as expected. Participants will initially maintain their usual routine, then switch to taking their medication at night to assess any differences. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance treatment strategies for young patients 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 there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that taking at least one blood pressure medication at bedtime, rather than in the morning, can safely help control blood pressure. Studies suggest that this timing can also reduce the risk of heart problems, such as heart attacks, in people with chronic kidney disease (CKD) and high blood pressure.
In some cases, taking medication at night helped most patients return to normal blood pressure patterns. One small study found that taking these medications in the evening significantly lowered heart-related issues for people with CKD.
These findings suggest that changing the timing of medication, without altering the medication itself, is generally safe for patients. This approach builds on treatments already used in various ways.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to managing pediatric chronic kidney disease through chronotherapy, which involves retiming the administration of anti-hypertensive drugs. Unlike traditional treatments that focus on the type or dosage of medication, this approach investigates the timing of drug delivery, specifically nighttime dosing. This could potentially improve blood pressure control by aligning medication administration with the body's natural rhythms, leading to more effective management of the condition with possibly fewer side effects. By comparing the current regimen to nighttime dosing, researchers hope to discover whether timing plays a crucial role in enhancing treatment outcomes for young patients.
What evidence suggests that re-timing of anti-hypertensive medication might be an effective treatment for pediatric chronic kidney disease?
Research has shown that taking blood pressure medication at night can be more effective than taking it in the morning. In this trial, one group of participants will continue with their current regimen, while another group will switch to nighttime dosing of one anti-hypertensive medication. Studies have found that evening dosing significantly lowers blood pressure during the night, which is especially beneficial for people with chronic kidney disease. For instance, one study found that taking medication at night reduced the systolic blood pressure by an average of 7 mm Hg at night, without affecting daytime blood pressure. Another study demonstrated that this approach helps maintain normal blood pressure patterns over 24 hours. These findings suggest that evening dosing could lead to better blood pressure control.678910
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