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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04591171

Collaborator

Children's Hospital of Philadelphia (Other)

Enrollment

Location

Arm

19.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertension Chronic Kidney Diseases	Procedure: n-of-1 trial guided clinical decision making	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 25, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: n-of-1 trial guided clinical decision making	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Change in 24-hour mean arterial pressure (MAP) [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.

Secondary Outcome Measures

Change in number of participants with target blood pressure [6 months]
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
Children's Hospital of Philadelphia

Investigators

Principal Investigator: Joyce P Samuel, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joyce Philip Samuel, Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04591171

Other Study ID Numbers:

HSC-MS-20-1005

First Posted:

Oct 19, 2020

Last Update Posted:

May 6, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joyce Philip Samuel, Associate Professor, The University of Texas Health Science Center, Houston

n-of-1 trial

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Hypertension

Study Results

No Results Posted as of May 6, 2021