Skip to main content
OpenTrials
Completed

NCT Number: NCT04591171

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants With Target Blood Pressure

    Time frame: 6 months

    Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.

  2. Number of Participants With Target Blood Pressure

    Time frame: baseline

    Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Children's Hospital of Philadelphia
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.