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

NCT ID: NCT04591171

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2022-02-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

n-of-1 trial guided clinical decision making

Group Type: EXPERIMENTAL

n-of-1 trial guided clinical decision making

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Joyce Philip Samuel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joyce P Samuel, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-20-1005

Identifier Type: -

Identifier Source: org_study_id