CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
n-of-1 trial guided clinical decision makingprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04591171
NCT04591171N/ACompleted

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

The University of Texas Health Science Center, Houston·interventional·Posted Oct 19, 2020·Updated Mar 20, 2023

In Brief

A clinical study evaluating n-of-1 trial guided clinical decision making for Hypertension and Chronic Kidney Diseases. Completed, enrolled 9 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartJan 25, 2021
Primary CompletionFeb 18, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

n-of-1 trial guided clinical decision makingprocedure

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.