Chronic Kidney Diseases, Hypertension
Conditions
Keywords
n-of-1 trial
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).
Interventions
PROCEDUREn-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.
Sponsors
Children's Hospital of Philadelphia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 22 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-of-1 Trial Guided Clinical Decision Making 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | N-of-1 Trial Guided Clinical Decision Making |
|---|---|
| Age, Categorical <=18 years | 9 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11 years |
| distance from home to clinic | 30 miles |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| glomerular filtration rate (GFR) | 65 mL/min/1.73m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
| Transplant or Dialysis Status Dialysis | 0 Participants |
| Transplant or Dialysis Status non-dialysis CKD | 5 Participants |
| Transplant or Dialysis Status Transplant | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in 24-hour Mean Arterial Pressure (MAP)
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.
Time frame: baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| N-of-1 Trial Guided Clinical Decision Making | Change in 24-hour Mean Arterial Pressure (MAP) | 1.4 mmHg | Standard Deviation 5.9 |
Secondary
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-of-1 Trial Guided Clinical Decision Making | Number of Participants With Target Blood Pressure | 4 Participants |
Secondary
Number of Participants With Target Blood Pressure
Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| N-of-1 Trial Guided Clinical Decision Making | Number of Participants With Target Blood Pressure | 3 Participants |