# Integrated Mineral Metabolism Treatment Strategies in Patients on Dialysis

> **NIH NIH R01** · UNIVERSITY OF VIRGINIA · 2020 · $282,638

## Abstract

PROJECT SUMMARY
Patients with end stage kidney disease on dialysis have deranged mineral metabolism, including often severe
changes in calcium, phosphorus, parathyroid hormone and the phosphorus-regulatory hormone fibroblast
growth factor 23. Pre-clinical studies strongly suggest that these mineral metabolism abnormalities may
directly increase risk of common morbidities in this group including cardiovascular and bone disease. These
potential effects in pre-clinical studies are supported by observational studies in patients linking mineral
metabolism abnormalities with morbidity and mortality. Although treatment of mineral metabolism
derangements is widespread in practice, there are no definitive trials demonstrating the best approaches to
prevent common adverse outcomes in patients on dialysis such as accelerated mortality, cardiovascular
disease and frequent hospital admissions. This application will utilize clinical practice data as well as patient
and provider engagement to design needed trials and overcome prior barriers to trial success such as high
rates of mineral metabolism treatment discontinuation and change. Because (1) multiple classes of
pharmacologic agents are available to treat mineral metabolism abnormalities; and, (2) guidelines advocate
broad ranges for biochemical parameters, such as phosphorus and parathyroid hormone, providers have many
choices for their overall approach to mineral metabolism treatment and demonstrate substantial variation in
approaches. This proposal will leverage real-world practice data derived from detailed medical records and
linked administrative claims in a large population of patients treated with in-center hemodialysis to understand
alternative treatment strategies and compare their outcomes. Aim 1 will define common treatment strategies
that incorporate different pharmacologic agent combinations, doses and mineral metabolite target values (i.e.,
integrated strategies), and identify predictors of different prescribing practices in this area using discrete choice
models. Aim 2 will evaluate the prospective association of integrated treatment strategies with adverse clinical
outcomes, including mortality, cardiovascular disease events, fracture, hospitalization and health-related
quality of life. Unique data elements, such as frequently updated medication and clinical data and facility
clustering are well-suited to marginal structural modeling and instrumental variable methods to better account
for potential confounding. In Aim 3, focus groups and directed interviews with patients and dialysis care
providers will be used to deeply evaluate underlying reasons for frequent discontinuation and change of the
treatment strategy that plagued prior trials. Ultimately, these studies will identify alternative strategies that are
practical in real-world settings, associated with the most optimal clinical outcomes and sustainable through
optimized care delivery, thereby solidifying the evidence-base for practic...

## Key facts

- **NIH application ID:** 9971263
- **Project number:** 7R01DK111952-04
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Julia J Scialla
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $282,638
- **Award type:** 7
- **Project period:** 2017-03-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9971263

## Citation

> US National Institutes of Health, RePORTER application 9971263, Integrated Mineral Metabolism Treatment Strategies in Patients on Dialysis (7R01DK111952-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9971263. Licensed CC0.

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