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

NCT04591171 | Completed Results

• 1 other identifier: HSC-MS-20-1005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypertension; Chronic Kidney Diseases

Keywords

n-of-1 trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Target Blood Pressure

  6 months

• Number of Participants With Target Blood Pressure

  baseline

Study Arms (1)

n-of-1 trial guided clinical decision making

EXPERIMENTAL

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

Interventions

n-of-1 trial guided clinical decision making PROCEDURE

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.

n-of-1 trial guided clinical decision making

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• hypertension
• CKD stage 2-5
• requiring antihypertensive medication per clinician judgement.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Children's Hospital of Philadelphia: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joyce P Samuel, MD, MS
• Organization: The University of Texas Health Science Center at Houston

joyce.samuel@uth.tmc.edu

713-500-6708

Study Officials

• Joyce P Samuel, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: January 25, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)