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Completed

Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE)

ClinicalTrials.gov ID NCT05169411
Sponsor Children's Hospital of Philadelphia
Information provided by Children's Hospital of Philadelphia (Responsible Party)
Last Update Posted 2024-08-16
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Study Overview

Brief Summary

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.

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Official Title
Preserving Kidney Function in Children With Chronic Kidney Disease (PRESERVE)
Conditions
Chronic Kidney Disease Stage 2
Chronic Kidney Disease Stage 3
Pediatric Kidney Disease
Intervention / Treatment
  • Diagnostic Test: Blood pressure
  • Diagnostic Test: Urine protein
  • Diagnostic Test: Blood pressure
  • Diagnostic Test: Urine protein
Other Study ID Numbers
  • 21-018814
  • RD-2020C22-0338 ( Other Identifier ) (OTHER: PCORI)
    RD-2020C22-0338 ( Other Identifier ) (OTHER: PCORI)
Study Start (Actual)
2023-09-22
Primary Completion (Actual)
2024-07-31
Study Completion (Actual)
2024-07-31
Enrollment (Actual)
20240
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19103

Children's Hospital of Philadelphia
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • Include: patient has an outpatient, ED, or inpatient visit with a physician
  • Include: 1 or more eGFR values 30-89 mL/min/1.73m2 using the CKiD U25 formula
  • Include: 2 or more eGFR values 30-89 mL/min/1.73m2 on different days using the CKiD U25 formula
  • Include: 2 eGFR values in the range 30-89 mL/min/1.73m2 using the CKiD U25 formula greater than or equal to 90 days apart.

Exclusion Criteria:

  • Exclude: eGFR value >=90 ml/min using the CKiD U25 formula between the two qualifying eGFRs in mild-moderate range
  • Exclude if: Age <1 and >=18 years on CED (see below for definition of CED)
  • Exclude if: no nephrologist visit at any time during the study period
  • Exclude: if chronic dialysis on or before CED
  • Exclude: if kidney transplant on or before CED
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Study Population
Children ages 1 to <18 years with chronic kidney disease stages 2-3 at cohort entrance.
Ages Eligible for Study
1 Year to 17 Years (Child )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Observational Model : Cohort
Time Perspective: Retrospective

Groups and Interventions

Groups/Cohorts Intervention/Treatment
Groups/Cohorts angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) categories
The first anti-hypertensive prescribed will be categorized as ACEi, ARB, thiazide diuretic, loop diuretic, beta-blocker, calcium channel blocker, other, and none.
Intervention/Treatment Diagnostic Test: Blood pressure
  • 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.

Groups/Cohorts Combined renin-angiotensin-aldosterone system (RAAS) blocker category
Secondary analyses will combine ACEi and ARB into a single RAAS blocker category.
Intervention/Treatment Diagnostic Test: Blood pressure
  • 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.

Groups/Cohorts Urine protein dichotomous indicator
We will determine whether urine protein is evaluated at each encounter and create a dichotomous indicator.
Intervention/Treatment Diagnostic Test: Urine protein
  • 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.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
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

up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Children's Hospital of Philadelphia
Collaborators
  • Patient-Centered Outcomes Research Institute
  • Children's Hospital Medical Center, Cincinnati
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Nationwide Children's Hospital
  • Seattle Children's Hospital
  • Stanford University
  • University of Colorado, Denver
  • Duke University
  • University of North Carolina, Chapel Hill
  • Indiana University
  • Medical College of Wisconsin
  • University of Iowa
  • Johns Hopkins University
  • University of Michigan
  • University of Florida
  • University of Miami
  • University of Pennsylvania
  • Alfred I. duPont Hospital for Children
  • Show fewer collaborators
Investigators
  • Principal Investigator:Chris Forrest, MD,Children's Hospital of Philadelphia
  • Principal Investigator:Michelle Denburg, MD,Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2021-11-11
First Submitted that Met QC Criteria
2021-12-23
First Posted
2021-12-27
Study Record Updates
Last Update Submitted that met QC Criteria
2024-08-14
Last Update Posted
2024-08-16
Last Verified
2024-08

More Information

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Keywords Provided by Children's Hospital of Philadelphia
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data are from electronic health records, so individual level patient data cannot be shared.