An observational study in Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3 and Pediatric Kidney Disease, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Children's Hospital of Philadelphia · Observational
Pediatric chronic kidney disease (CKD) results from health conditions that reduce kidney function for >3 months. It can progress to end-stage kidney disease (ESKD), which requires dialysis or kidney transplant. In adults, CKD is common and caused mainly by hypertension and diabetes. CKD in childhood is rare and caused primarily by congenital anomalies of the genitourinary system and immune-mediated disorders. The best estimate of pediatric CKD prevalence is \<1/15,000 pediatric population. Hypertension occurs in 50% of affected children and is a major risk factor for decline in kidney function. Several clinical practice guidelines have offered recommendations for blood pressure (BP) management in pediatric CKD; however, clinical trial and large-scale observational data are limited, leading to a weak evidence base and substantial practice variation. The purpose of PRESERVE is to provide new knowledge to inform shared decision-making regarding BP management for pediatric CKD. We will leverage the Patient-Centered Outcomes Research network (PCORnet®) infrastructure to conduct large-scale observational studies that will address BP management knowledge gaps for pediatric CKD and sub-groups for whom antihypertensive treatment and outcome associations may be different (e.g., cause of kidney disease and proteinuria).
The project's specific aims are:
Aim 1-Enhance the PCORnet Common Data Model (CDM) for pediatric and rare kidney disease research. We will expand and improve the PCORnet CDM with new pediatric- and kidney-specific variables, study-specific data quality optimization, and linkage with the chronic kidney disease in children (CKiD) cohort study and the US Renal Data System (USRDS). CKiD directly measures kidney function [ie, glomerular filtration rate (GFR)] and includes Ambulatory Blood Pressure Monitoring (ABPM). The USRDS provides complete capture of renal replacement therapy [(RRT) dialysis and transplant], two components of the primary clinical outcome.
Aim 2-Describe and examine the effectiveness of consistent BP and urine protein monitoring for preserving kidney function. We will describe the consistency of BP and urine protein monitoring and will contrast clinic BP assessments with ABPM. In longitudinal analyses, we will evaluate the effects of consistent monitoring of BP and urine protein on kidney function decline.
Aim 3-Compare the effectiveness of BP medication strategies for preserving kidney function. We will compare the effects of (1) BP levels when treatment was started, (2) choice of first-line therapies, and (3) ongoing BP control on kidney function decline. We will also assess adverse events related to hypertension management.
Aim 4-Assess patients' lived experiences related to BP management. We will field a survey that examines patient-centered outcomes by level of BP control and medication management approaches. This Aim will provide information on experiences with BP management from the perspectives of patients, parents, and clinicians that will complement the clinical outcomes studied in Aims 2 and 3.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 20,240 is above the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Children ages 1 to \<18 years with chronic kidney disease stages 2-3 at cohort entrance.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none.
Diagnostic Test: Blood pressure
Secondary analyses will combine ACEi and ARB into a single RAAS blocker category.
Diagnostic Test: Blood pressure
We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator.
Diagnostic Test: Urine protein
The first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none; secondary analyses will combine ACEi and ARB into a single RAAS blocker category. We will conduct additional secondary analyses for specific medications with sufficient sample sizes.
Evaluating urine protein for children with CKD and hypertension is another guideline recommendation, but the frequency, type of assessment (qualitative or quantitative urine protein), and utility for patients without hypertension are unclear. We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator.
Decline in estimated glomerular filtration rate (eGFR)
Time from cohort entrance (defined as day when first estimated glomerular filtration rate will be measured by the following criteria: (1) \>50% decline in eGFR, as measured by the U25 formula; (2) eGFR \<=15 ml/min as measured by the U25 formula); (3) initiation of chronic dialysis; or (4) kidney transplant. U25 formula: https://doi.org/10.1016/j.kint.2020.10.047
Time frame: up to 18 months
Plan to share: No — Data are from electronic health records, so individual level patient data cannot be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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