Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease

Hypertension Clinical Trial

Official title:

Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591171
• Other study ID #: HSC-MS-20-1005
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: February 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 22 Years

Eligibility

Inclusion Criteria:

• hypertension

• CKD stage 2-5

• requiring antihypertensive medication per clinician judgement.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• n-of-1 trial guided clinical decision making
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.

Locations

Country	Name	City	State
United States	University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 6 months
Secondary	Number of Participants With Target Blood Pressure	Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.	6 months
Secondary	Number of Participants With Target Blood Pressure	Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.	baseline