Clinical Trials Program

The University of Michigan Pediatric Nephrology Research Program offers clinical trials for children and adults with kidney disease. Through an established partnership across the Glomerular Disease Clinics in both pediatrics and internal medicine, the program can provide expertise in the care of clinical trial patients with rare kidney disease.

To speak with a member of the trials team, please email umkidneystudies@umich.edu.

Currently enrolling:

  • TNF Precision Medicine clinicaltrials.gov/NCT04009668. A proof of concept, open label clinical trial addressing the treatment of patients with FSGS or treatment resistant MCD. Participants with up-regulation of urinary biomarkers for intra-renal tumor necrosis factor (TNF) will be treated with 8 weeks of adalimumab therapy. The study tests the hypothesis that TNF inhibition in patients with up-regulation of the intra-renal TNF pathway will result in reduction in TNF associated urinary biomarker levels.
  • EPPIK clinicaltrials.gov/NCT05003986. Open label clinical trial of Sparsentan to evaluate safety and efficacy on proteinuria and kidney function in children with FSGS, MCD, IgAN, IgAV, and Alports Syndrome.
  • SCD PED-02 clinicaltrials.gov/NCT04869787. Open label clinical trial examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI).
  • TRPC6 Inhibition in FSGS clinicaltrials.gov/NCT05213624. Randomized, double-blind study to investigate the efficacy, safety, and tolerability of BI764198 vs placebo in FSGS
  • TRACTION clinicaltrials.gov/NCT04387448. Randomized, blinded study of TRPC5 inhibitor vs placebo to evaluate safety and tolerability of GFB-887 in adults with FSGS and Minimal Change Disease.
  • APPLAUSE clinicaltrials.gov/NCT04578834. Randomized, double-blind trial to investigate the efficacy and safety of LNP023, an oral factor B inhibitor, vs placebo in treatment of adults with primary IgA nephropathy.
  • LNP023 vs rituximab in membranous nephropathy clinicaltrials.gov/ NCT04154787.  A phase II study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with MN who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria.

Closed to enrollment

  • DUPLEX clinicaltrials.gov/NCT03493685. A phase III long-term safety and efficacy study of Sparsentan, a novel dual endothelin receptor and angiotensin receptor blocker compared to Irbesartan as an active control in patients with FSGS.  Learn more at www.fsgsduplex.com/
  • EAGLE clinicaltrials.gov/NCT03749447.  A phase III study and open access program for the treatment of Alport’s disease using bardoxolone methyl.