# Applying Hypertension Clinical Trials to Real World Adults with CKD

> **NIH NIH R01** · PALO ALTO VETERANS INSTIT FOR RESEARCH · 2022 · $649,363

## Abstract

PROJECT SUMMARY / ABSTRACT
Hypertension affects more than 80% of adults with chronic kidney disease (CKD), and its treatment is a
cornerstone of CKD management. Clinical guidelines vary in their recommendations for blood pressure targets
in CKD, reflecting uncertainties in the interpretation of the Systolic Blood Pressure Intervention Trial (SPRINT)
and its extrapolation to adults with CKD, particularly those with advanced CKD. Although evidence from
randomized trials has strong internal validity, it may not reflect the risk benefit profile of patient populations that
will receive treatment in practice. Our overarching goal is to evaluate the comparative risks and benefits of
intensive versus standard blood pressure targets in real world adults with CKD. Our secondary goal is to
demonstrate the feasibility and utility of novel analytical approaches that extend causal effects from
randomized trial effects to broader populations. We will accomplish these goals by leveraging electronic health
record data from two large health care systems encompassing 13 million enrollees - the Veterans Health
Administration and Kaiser Permanente of Southern California. To inform our real-world estimates, we will
integrate individual-level data from four diverse hypertension trials on 20,000 participants. In Aim 1, we will
estimate average treatment effects of intensive versus standard blood pressure targets among SPRINT-eligible
real world adults with CKD. In Aim 2, we will develop and validate models for individualized prediction of
intensive blood pressure treatment effects, and illustrate the application in real world CKD populations. In Aim
3, we will emulate a sequential clinical trial of blood pressure medication intensification using electronic health
records in persons with CKD. Our study is important because hypertension treatment affects nearly all adults
with CKD and key evidence gaps may lead to suboptimal management in this high-risk population. It is
innovative because it will provide new evidence about the implications of intensive blood pressure targets and
new analytic approaches to support clinical decisions with real world data.

## Key facts

- **NIH application ID:** 10494235
- **Project number:** 5R01DK128108-02
- **Recipient organization:** PALO ALTO VETERANS INSTIT FOR RESEARCH
- **Principal Investigator:** MANJULA KURELLA TAMURA
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $649,363
- **Award type:** 5
- **Project period:** 2021-09-24 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10494235

## Citation

> US National Institutes of Health, RePORTER application 10494235, Applying Hypertension Clinical Trials to Real World Adults with CKD (5R01DK128108-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10494235. Licensed CC0.

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