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The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods
Journal article   Open access   Peer reviewed

The Preserving Kidney Function in Children With CKD (PRESERVE) Study: Rationale, Design, and Methods

Michelle R. Denburg, Hanieh Razzaghi, Amy J. Goodwin Davies, Vikas Dharnidharka, Bradley P. Dixon, Joseph T. Flynn, Dorey Glenn, Caroline A. Gluck, Lyndsay Harshman, Aneta Jovanovska, …
Kidney medicine, Vol.5(11), 100722
11/2023
DOI: 10.1016/j.xkme.2023.100722
PMCID: PMC10641283
PMID: 37965485
url
https://doi.org/10.1016/j.xkme.2023.100722View
Published (Version of record) Open Access

Abstract

Rationale & Objective PRESERVE seeks to provide new knowledge to inform shared decision-making regarding blood pressure (BP) management for pediatric chronic kidney disease (CKD). PRESERVE will: compare the effectiveness of alternative strategies for monitoring and treating hypertension on preserving kidney function; expand the PCORnet® common data model by adding pediatric- and kidney-specific variables and linking electronic health record data to other kidney disease databases; and assess the lived experiences of patients related to BP management. Study Design Multicenter retrospective cohort study (clinical outcomes) and cross-sectional study (patient-reported outcomes [PROs]). Setting & Participants PRESERVE will include nearly 20,000 children between January 2009-December 2022 with mild-moderate CKD from 15 healthcare institutions that participate in 6 PCORnet Clinical Research Networks (PEDSnet, STAR, GPC, PaTH, CAPRiCORN, OneFlorida+). Inclusion criteria: ≥1 nephrologist visit and ≥2 estimated glomerular filtration rate (eGFR) values in the range of 30- <90 mL/min/1.73m2 separated by ≥90 days without intervening value ≥90 mL/min/1.73m2 and no prior dialysis or kidney transplant. Exposures BP measurements (clinic-based and 24-hour ambulatory BP); urine protein; antihypertensive treatment by therapeutic class. Outcomes The primary outcome is a composite event of 50% reduction in eGFR, eGFR <15 mL/min/1.73m2, long-term dialysis or kidney transplant. Secondary outcomes include change in eGFR, adverse events, and PROs. Analytical Approach Longitudinal models for dichotomous (proportional hazards or accelerated failure time) and continuous (generalized linear mixed models) clinical outcomes, and multivariable linear regression for PROs. We will evaluate heterogeneity of treatment effect by CKD etiology and degree of proteinuria and will examine variation in hypertension management and outcomes by socio-demographics. Limitations Causal inference limited by observational analyses. Conclusions PRESERVE will leverage the PCORnet® infrastructure to conduct large-scale observational studies that address BP management knowledge gaps for pediatric CKD, focusing on outcomes that are meaningful to patients.

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