HypertensionNCT04591171
Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease
A study testing n-of-1 trial guided clinical decision making in people with Hypertension and Chronic Kidney Diseases, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 5 to 22 years
- Conditions the study is for
- Hypertension, Chronic Kidney Diseases
- What is being tested?
- n-of-1 trial guided clinical decision making
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- hypertension
- CKD stage 2-5
- requiring antihypertensive medication per clinician judgement.
Who cannot join
- renal transplant anticipated or occurred within 6 months of screening
- transfer out of our practice setting anticipated within 6 months
- unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics
Houston, Texas, 77030
About this study
Official title: Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
- Conditions
- Hypertension, Chronic Kidney Diseases
- Being tested
- n-of-1 trial guided clinical decision making
- Keywords
- n-of-1 trial
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-of-1 trial guided clinical decision makingProcedure or surgery
The n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug.
| Study group | Role | What they receive |
|---|---|---|
| n-of-1 trial guided clinical decision making | Experimental | Not described Receives: Procedure: n-of-1 trial guided clinical decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour Mean Arterial Pressure (MAP)
24-hour mean arterial pressure (MAP) is the mean arterial pressure over 24 hours [ambulatory blood pressure monitoring (ABPM) will be used to record blood pressure every 20 min for 24 hours, and all recordings will be averaged to obtain 24-hour MAP]. 24-hour MAP will be assessed at baseline and at 6 months, and the change between baseline and 6-months will be reported.
Measured: baseline, 6 months
Secondary outcomes (2)
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Measured: 6 months
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Jan 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Joyce Philip Samuel, The University of Texas Health Science Center, Houston
- Investigators
- Joyce P Samuel, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591171
- Sponsor's protocol ID
- HSC-MS-20-1005
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2020
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04591171
- Acronym / sponsor ID
- HSC-MS-20-1005
- Conditions
- Hypertension, Chronic Kidney Diseases
- Keywords
- n-of-1 trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| n-of-1 trial guided clinical decision making | Experimental | Procedure: n-of-1 trial guided clinical decision making |
Who may qualify
- Ages
- 5 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- hypertension
- CKD stage 2-5
- requiring antihypertensive medication per clinician judgement.
Key exclusion criteria (3 listed)
- renal transplant anticipated or occurred within 6 months of screening
- transfer out of our practice setting anticipated within 6 months
- unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations
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 |
|---|---|---|
| n-of-1 trial guided clinical decision makingThe n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug. | Procedure or surgery | n-of-1 trial guided clinical decision making |
Primary outcome
Change in 24-hour Mean Arterial Pressure (MAP)
Time frame: baseline, 6 months
24-hour mean arterial pressure (MAP) is the mean arterial pressure over 24 hours [ambulatory blood pressure monitoring (ABPM) will be used to record blood pressure every 20 min for 24 hours, and all recordings will be averaged to obtain 24-hour MAP]. 24-hour MAP will be assessed at baseline and at 6 months, and the change between baseline and 6-months will be reported.
2 secondary outcomes
Number of Participants With Target Blood Pressure
Time frame: 6 months
Number of Participants With Target Blood Pressure
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Joyce P Samuel, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-of-1 trial guided clinical decision making in people with Hypertension and Chronic Kidney Diseases, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 20 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in 24-hour Mean Arterial Pressure (MAP) (time frame: baseline, 6 months). 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 20 Mar 2023.