Study

Alternative Approaches for Managing Blood Pressure in Children with Chronic Kidney Disease (PRESERVE 2.0)


Study Dates
2026-10 - Present
Principal Investigator
Denburg, Michelle , Forrest, Christopher
Affiliation
Children's Hospital of Philadephia
Sponsor Site
Children's Hospital of Philadelphia
PEDSnet Study ID
2026.DENM.PCORI.CHOP.895

Study to determine clinic blood pressure thresholds for kidney and cardiovascular protection of children with CKD, and whether RAASi should be the first-line anti-hypertensive therapy for all children with CKD.

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Funding

This research was made possible through the generous support of Patient-Centered Outcomes Research Institute. The statements presented in this work are solely the responsibility of the author(s) and do not necessarily represent the views of PCORI, its Board of Governors, or its Methodology Committee.

Creative Commons license

a CC-BY Attribution 4.0 license.
Except where otherwised noted, this item's license is described as a CC-BY Attribution 4.0 license.

Publisher

PEDSnet

Project Description

The proposed study was motivated by the PCORI-funded and PCORnet-designated PRESERVE (Preserving Kidney Function in Children with Chronic Kidney Disease) study, which included >20,000 children with chronic kidney disease (CKD). PRESERVE conducted large observational analyses that highlighted the validity of clinic blood pressure (BP) for assessment of BP control, the impact of BP control on preservation of kidney function, and the beneficial effects of renin-angiotensin-aldosterone system inhibition (RAASi) for anti-hypertensive therapy in pediatric CKD. The randomized controlled pragmatic trial proposed herein, called PRESERVE 2.0, was designed by the PRESERVE community and builds on the infrastructure and findings generated in PRESERVE to address two high-priority questions:

  1. What clinic BP threshold should be targeted for kidney and cardiovascular protection in children with CKD?
  2. Should RAASi be first-line anti-hypertensive therapy for all children with CKD?

Study Aims

  1. Optimizing Trial Infrastructure: Establish the pragmatic trial infrastructure by building on existing resources in PCORnet, PEDSnet, and PRESERVE.
  2. Conventional versus Intensified BP control: We will compare the effects of conventional (<90th percentile), guideline-based BP control versus treating to a target of the 50th percentile of clinic systolic BP on clinical and quality of life outcomes in children with CKD.
  3. Comparative Effectiveness of RAASi versus CCB: We will compare the effects of RAASi and CCB as first-line anti-hypertensive therapy on clinical and quality of life outcomes in children with non-glomerular, non-proteinuric CKD.

Study Design

Leveraging the PCORnet and PRESERVE infrastructure, we propose a pragmatic, randomized controlled trial. The trial will evaluate 1) superiority of intensified vs. conventional BP control and 2) superiority of RAASi vs. CCB as first-line anti-hypertensive therapy in non-glomerular, non-proteinuric CKD. Participants with glomerular and/or proteinuric CKD will all receive RAASi and undergo randomization to parallel arms of intensified vs. conventional BP control. Participants with non-glomerular CKD and no proteinuria will be randomized in a factorial design to the 4 combinations of intensified vs. conventional BP control and RAASi vs. CCB.

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