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Division of Nephrology Heersink School of Medicine

Clinical Trials Research

 ONGOING CLINICAL TRIAL STUDIES:

  • Study title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study).

Protocol number: CEXV811A12301 (CHK01-01)

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A randomized, multicenter, double-blind, parallel-group, active-control study of the efficacy and safety of sparsentan for the treatment of immunoglobulin A nephropathy.

Protocol number: 021IGAN17001

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: 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.

Protocol number: 417-201-00007

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy.

Protocol number: 417-201-00012

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults with IgA Nephropathy (The BEYOND Study).

Protocol number: CHK02-02 (Novartis CFUB523A12301)

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN).

Protocol number: VT-001-0050

PI: Dana Rizk, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu

  • Study title: A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sefaxersen, an antisense inhibitor of complement factor B, in patients with primary IgA nephropathy at high risk of progression.

Protocol number: WA43966

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease.

Protocol number: VX21-147-301

PI: Dana Rizk, MD

Study coordinator: Maria El Hachem, mehachem@uabmc.edu

  • Study title: A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB).

Protocol number: DMX-200-301

PI: Dana Rizk, MD

Study coordinator: Maria El Hachem, mehachem@uabmc.edu

  • Study title: A parallel-group treatment, Phase 2a, multicenter, randomized, double-blind, placebo-controlled umbrella study to evaluate the efficacy and safety of frexalimab, brivekimig, and rilzabrutinib in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD).

Protocol number: ACT18064

PI: Dana Rizk, MD

Study coordinator: Maria El Hachem, mehachem@uabmc.edu

  • Study title: An open-label study to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice.

Protocol number: Nef-403

PI: Dana Rizk, MD

Study coordinator: Amy Bottomlee, amybottomlee@uabmc.edu

  • Study title: A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults with Immunoglobulin A Nephropathy.

Protocol number: 417-201-00060

PI: Dana Rizk, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu

  • Study title: A multicenter, single arm, open label biopsy study to evaluate structural and functional changes in kidneys of adult patients with IgA nephropathy receiving iptacopan on top of supportive care.

Protocol number: CLNP023A2201

PI: Dana Rizk, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu

  • Study title: CureGN: Cure Glomerulonephropathy Network.

PI: Dana Rizk, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu

  • Study title: CureGN-Diabetes: Ancillary Study to CureGN.

PI: Dana Rizk, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu

  • Study title: Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy.

Protocol number: ITN080AI: REBOOT

PI: Dana Rizk, MD

Study coordinator: Maria El Hachem, mehachem@uabmc.edu

  • Study title: A Study to Determine the Prevalence and Clinical Characteristics Associated With PKD1 Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Protocol number: VX24-KDO-901

PI: Michal Mrug, MD

Study coordinator: Maria El Hachem, mehachem@uabmc.edu

  • Study title: A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease.

Protocol number: ID-069A302

PI: Eric Wallace, MD

Study coordinator: Christina Desruisseau, csingleton@uabmc.edu

  • Study title: A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry disease and left ventricular hypertrophy.

Protocol number: EFC16158

PI: Eric Wallace, MD

Study coordinator: Christina Desruisseau, csingleton@uabmc.edu

  • Study title: Vonafexor Fixed Dose-Escalation Safety and Proof-of-Concept Study in Patients with at Risk of Progression Alport Syndrome.

Protocol number: EYP001-208

PI: Eric Wallace, MD

Study coordinator: Christina Desruisseau, csingleton@uabmc.edu

  • Study title: A Phase 1/2, Single Dose, Dose Ranging Study of Intravenous AAV5-GLA (AMT-191) in Adult Males with Classic Fabry Disease.

Protocol number: CT-AMT-191-01

PI: Eric Wallace, MD

Study coordinator: Christina Desruisseau, csingleton@uabmc.edu

  • Study title: A Randomized Controlled Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis: The AV ACCESS Trial.

PI: Michael Allon, MD

Study coordinator: Ashlee Chatham, ashleechatham@uabmc.edu