NCT04591171

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 5 Years – 22 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-02-18
• Completion: 2022-02-18
• First posted: 2020-10-19
• Last updated: 2023-03-20
• Results posted: 2023-03-20

Locations

1 site across 1 country: United States