Chronic Kidney DiseasesNCT05353335
Chronotherapy in Children With Chronic Kidney Disease
A study testing Re-timing of anti-hypertensive drug and Current regimen in people with Chronic Kidney Diseases and Hypertension, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- What is being tested?
- Re-timing of anti-hypertensive drug and Current regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Children's Hospital/Yale New Haven Health
New Haven, Connecticut, 06520
About this study
Official title: Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease
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.
Read the detailed description
Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, randomized cross-over trial. The main purpose of this study is to investigate whether non-dipping can be modified with retiming of anti-hypertensives in children with CKD. This is important because in adults, non-dipping has been associated with increased cardiovascular disease risk and more rapid progression of kidney disease. Thus, identification of how to modify this in children with CKD, may lead to future randomized controlled trials to evaluate whether chronotherapy improves outcomes in this population, which is at high risk for morbidity and mortality in adulthood.
The primary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal systolic blood pressure change (%) in children with CKD, hypertension and non-dipping.
The secondary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal diastolic blood pressure change (%) in children with CKD, hypertension and non-dipping. Another secondary objective is to determine if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives.
- Conditions
- Chronic Kidney Diseases, Hypertension
- Being tested
- Re-timing of anti-hypertensive drug, Current regimen
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-timing of anti-hypertensive drugOther
The intervention will consist of shifting the anti-hypertensive medication from morning/early dose to an evening/later dose
Current regimenOther
The participants will begin on their current regimen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Current regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 1
Secondary outcomes (2)
Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.
Percent change in systolic nocturnal blood pressure will be calculated as: (daytime mean DBP - nighttime mean DBP)/daytime mean DBP x 100 to assess if nocturnal BP dipping can be restored.
Measured: 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
This outcome will assess if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives. Restoration of dipping would mean that both systolic and diastolic nocturnal blood pressure change are greater than or equal to 10%, after the intervention.
Measured: Baseline and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study startApr 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: not justified based on recent analyses of non-dipping in children with CKD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Responsible party
- Sponsor
- Investigators
- Christine Bakhoum, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353335
- Sponsor's protocol ID
- 2000031575
- Other IDs
- 1K23DK129836-01
- Status last verified
- Jun 2025
- First submitted
- 25 Apr 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05353335
- Acronym / sponsor ID
- 2000031575
- Conditions
- Chronic Kidney Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not justified based on recent analyses of non-dipping in children with CKD
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, randomized cross-over trial. The main purpose of this study is to investigate whether non-dipping can be modified with retiming of anti-hypertensives in children with CKD. This is important because in adults, non-dipping has been associated with increased cardiovascular disease risk and more rapid progression of kidney disease. Thus, identification of how to modify this in children with CKD, may lead to future randomized controlled trials to evaluate whether chronotherapy improves outcomes in this population, which is at high risk for morbidity and mortality in adulthood.
The primary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal systolic blood pressure change (%) in children with CKD, hypertension and non-dipping.
The secondary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal diastolic blood pressure change (%) in children with CKD, hypertension and non-dipping. Another secondary objective is to determine if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nighttime dosing of one anti-hypertensive medication | Experimental | Other: Re-timing of anti-hypertensive drug13 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. |
| remain on their current regimen | Active comparator | Other: Current regimen13 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-timing of anti-hypertensive drugThe intervention will consist of shifting the anti-hypertensive medication from morning/early dose to an evening/later dose | Other | nighttime dosing of one anti-hypertensive medication |
| Current regimenThe participants will begin on their current regimen. | Other | remain on their current regimen |
Primary outcome
Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).
Time frame: Baseline and Month 1
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.
2 secondary outcomes
Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.
Time frame: 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
Time frame: Baseline and Month 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Bakhoum principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-timing of anti-hypertensive drug and Current regimen in people with Chronic Kidney Diseases and Hypertension, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM). (time frame: Baseline and Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.