St. Clair Nephrology Studies

Hypertension:

 

  • Analym (Kardia 3) : A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients with High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications.  

PI: Provenzano; Coordinator: Sherry x1264

https://clinicaltrials.gov/study/NCT06272487

 

Polycystic Kidney Disease: 

 

  • Regulus PKD: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Patients with Autosomal Dominant Polycystic Kidney Disease to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RGLS8429(miRNA).   

PI: Bellovich; Coordinator: Rosemarie x1251. 

https://clinicaltrials.gov/study/NCT05521191

 

IgA Nephropathy:

 

  • Otsuka: IgAN – A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy. 

PI: Topf; Coordinator: Rosemarie X1251. 

https://clinicaltrials.gov/study/NCT05248646

https://clinicaltrials.gov/study/NCT05248659

 

  • Alpine Sciences: RANIER A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy. 

PI: Topf; Coordinator: Liz x1047.

https://clinicaltrials.gov/study/NCT06564142

 

Transplant:

 

  • APOLLO: (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Consortium is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation.

 PI: Bellovich; Sherry x1264

https://clinicaltrials.gov/study/NCT03615235

 

Chronic Kidney Disease: 

 

  • EASI-Kidney: Studies of Heart & Kidney Protection with BI 690517: A multicenter international randomized double-blind placebo-controlled clinical trial of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in patients with chronic kidney disease.  

PI: Provenzano; Coordinator: Liz x1047

https://clinicaltrials.gov/study/NCT06531824

 

  • ProKidney: A Phase 3 Randomized Controlled Study of Re Autologous Cell Therapy (REACT) in Subjects with Type 2 Diabetes and CKD.  

PI: Bellovich; Coordinator: Sherry x1264. 

https://clinicaltrials.gov/study/NCT05099770

 

Renal Amyloidosis:

 

  • FLORAL: DapagliFLOzin in Renal AL Amyloidosis (FLORAL) This study aims to study the safety and efficacy of dapagliflozin, a sodiumglucose cotransporter-2 inhibitor (SGLT2i) in patients with renal amyloid light-chain (AL) amyloidosis in a decentralized manner.  

PI: Topf; Coordinator: Lori x1224

https://clinicaltrials.gov/study/NCT06420167

 

 

End Stage Renal Disease on Dialysis:

 

  • CSL Behring: Phase 3: (continuation of Phase 2b Multicenter, Randomized, Double-blind, Placebo-controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis. 

PI: Topf; Coordinator: Rosemarie x1251.

https://clinicaltrials.gov/study/NCT05485961

 

  • Merck: Phase II randomized placebo controlled outcomes trial of prevention of AVG thrombosis and safety of MK-2060 (a factor XI inhibitor) in ESRD pts. In long-term follow up. 

PI: Topf; Coordinator: Lori X1224. 

https://clinicaltrials.gov/study/NCT05027074

 

  • Pathalys: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Dose-Titrated PLS240 in the Treatment of Secondary Hyperparathyroidism in Individuals with End Stage Kidney Disease on Hemodialysis (PATH-2) with an Open-Label Extension. 

PI: Dimitrijevic; Coordinator: Sherry x1264.

https://clinicaltrials.gov/study/NCT05836220