St. Clair Nephrology Studies

Hypertension: 

  • 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

 

  • Novartis: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Patients with
    Autosomal Dominant Polycystic Kidney Disease to Evaluate the Efficacy and Safety of Farabursen

PI: Bellovich; Coordinator: Rosemarie.

 

Glomerular: 

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

PI: Topf; Coordinator: Liz

https://clinicaltrials.gov/study/NCT06989359

 

  • Walden Biosciences: Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients with Glomerular Kidney Diseases and Proteinuria

PI: Topf; Liz

https://clinicaltrials.gov/study/NCT06466135

 

  • Biohaven: An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy

PI: Topf; Liz

https://clinicaltrials.gov/study/NCT07054684

 

  • 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

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

https://clinicaltrials.gov/study/NCT06564142

 

  • BI: BI434-0017 A multicentre, randomised, double-blind, parallel group, placebo-controlled trial
    to assess the effects of oral TRPC6 inhibitor BI 764198 taken over a 104 week treatment period in adult and adolescent participants with primary focal segmental glomerulosclerosis (pFSGS) or genetic FSGS related to TRPC6 gene variants.

PI: Bellovich; Coordinator: Liz

https://clinicaltrials.gov/study/NCT07220083

 

  • BI: 1434-0027 PODOMOUNT: Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases

PI: Dimitrijevic; Coordinator: Liz

https://clinicaltrials.gov/study/NCT07355296

 

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

 

  • AP306-HP-202: A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants with Hyperphosphatemia Receiving Maintenance Hemodialysis

PI: Topf; Coordinator: Rosemarie

https://clinicaltrials.gov/study/NCT06712654

 

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