IGNITE hit a major milestone on July 10, 2020: The University of Florida randomized the first patient in to the GUARDD-US pragmatic clinical trial.
Genetic testing to Understand Renal Disease Disparities across the US (GUARDD-US) will investigate the results of apolipoprotein L1 (APOL1) genotyping in an African American population.
The primary outcome is systolic blood pressure (SBP) at three months comparing patients with high-risk APOL1 variants (positives) versus no high-risk variants (negatives). The co-primary outcome is three-month SBP in positives versus those receiving delayed testing. Secondary outcomes include renal disease testing, and psycho-behavioral factors. The team will re-randomize APOL1 negative patients to a genotype-guided approach to anti-hypertensive therapy versus usual care and compare three-month SBP.