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 x3009

https://clinicaltrials.gov/study/NCT06272487

 

  • Alnylam (ZENITH): Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease (ZENITH)

PI: Henderson; Coordinator: Sherry x3009

https://clinicaltrials.gov/study/NCT07181109

 

Polycystic Kidney Disease: 

 

  • AbbVie: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABBV-CLS-628 in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

PI: Bellovich; Coordinator: Rosemarie x1251

https://clinicaltrials.gov/study/NCT06902558

 

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 x1211

https://clinicaltrials.gov/study/NCT06564142

 

  • ADARx: A Phase 2 Study to Assess ADX-038 in Participants with Complement-Mediated Kidney Disease.

PI: Topf; Liz x1047

 

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: Sherry x3009

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 x3009

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.

Sub-I: Topf; Coordinator: Lori x1224

https://clinicaltrials.gov/study/NCT06420167

 

  • EXPAND: Expanding and Promoting Alternative Care and Knowledge in Decision Making: The ExPAND Study (Improving Shared Decision-Making and Access to Non-Dialytic Treatment for People with Kidney Disease (Patient Centered Outcome Research Institute): Patient choice in Kidney Failure Project. West Virginia University.

PI: Bellovich; Liz x1211

 

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

 

APOL1-Mediated Kidney Disease:

 

  • MAZE Therapeutics: An Open-Label Phase 2 Study to Evaluate the Safety, Tolerability, and Effect on Albuminuria of MZE829 in Adults with Proteinuric Chronic Kidney Disease and the APOL1 High Risk Genotype

PI: Provenzano; Coordinator: Rosemarie x1251

https://clinicaltrials.gov/study/NCT06830629

 

  • AstraZeneca: Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)

PI: Provenzano; Coordinator: Rosemarie x1251

https://clinicaltrials.gov/study/NCT06824987