# Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia

> **NIH NIH R01** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2021 · $107,440

## Abstract

Project Summary/Abstract
The parent R01 will develop and validate a novel eGFR equation and measure changes in GFR
over one year. Individuals with sickle cell anemia (SCA) are at an increased risk for the
development of venous thromboembolism (VTE). This risk likely increases further in the setting
of progressive kidney disease. In addition, thrombotic events may hasten the progression to end-
stage renal disease in individuals SCA. Prospective studies are need to examine the tri-directional
associations between SCA, chronic kidney disease, and thrombotic events. This proposal will
prospectively examine the prevalence of VTE in 200 pediatric and 200 adult participants with SCA
at baseline and the incidence of new and recurrent VTE at one year. This data will provide
prospective evidence to support prior cohort data suggesting a 10-20% one-year recurrence rate
for VTE in those with SCA who have had a first thrombotic event. Next, this proposal will
characterize the current treatment approaches to secondary thrombosis at baseline and
adherence to secondary thromboprophylaxis treatment at one year. The current ASH Sickle Cell
Guidelines were unable to provide strong recommendations due to the lack of solid evidence in
the field. Finally, the proposal will measure the trajectory of GFR changes in participants with and
without a history of thrombosis. Exploratory analysis will also compare the trajectory for
participants with a new thrombotic event during the study period. This data is vital to determine
whether a history of thrombotic events should be included in the stratification of renal outcomes
for future studies of renoprotective agents in SCA. Each of these aims will provide vital preliminary
data to support a feasibility trial of anticoagulation in individuals with SCA who have a history of
thrombotic events as well as broader trials in children with VTE and persistent thrombotic risk
factors.

## Key facts

- **NIH application ID:** 10244787
- **Project number:** 3R01HL153386-01S1
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** Jeffrey D Lebensburger
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $107,440
- **Award type:** 3
- **Project period:** 2021-03-04 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10244787

## Citation

> US National Institutes of Health, RePORTER application 10244787, Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia (3R01HL153386-01S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10244787. Licensed CC0.

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