Kidney Compass: Navigating Clinical Trials

Kidney Compass: Navigating Clinical Trials

Hosted by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, Kidney Compass: Navigating Clinical Trials is a regular podcast exploring and breaking down the latest updates and nuances of clinical trials in nephrology. By listening to Kidney Compass, you'll get the guidance you need to navigate the changing landscape of clinical trials across the spectrum of kidney disease.

  1. Apr 14

    IV Iron and Functional Outcomes in Kidney Transplant Recipients

    Iron deficiency is increasingly recognized as a clinically meaningful yet underexplored contributor to morbidity in kidney disease, extending beyond its traditional association with anemia. In populations such as kidney transplant recipients, where graft function may be stable, many patients continue to experience impaired physical function, reduced quality of life, and lingering fatigue. As evidence from other fields, particularly cardiology, has begun to demonstrate the benefits of intravenous iron on functional outcomes independent of hemoglobin, questions are emerging about whether similar strategies could improve how patients with kidney disease feel and function, not just how they measure on laboratory parameters. In this episode of Kidney Compass recorded on-site at World Congress of Nephrology in Yokohama, Japan, hosts Shikha Wadhwani, MD, MS, and Brendon Neuen, MBBS, PhD, spoke with Martin de Borst, MD, PhD, about his investigator-initiated randomized trial of intravenous iron in kidney transplant recipients. 0:00:00 – Episode intro & topic framing0:01:11 – Rationale & observational signals0:03:03 – Choice of primary endpoint (6‑minute walk)0:04:35 – Trial design & blinding details0:05:11 – Inclusion criteria & population profile0:07:48 – Dosing regimen & primary outcome result0:09:03 – Secondary outcomes & “fixed labs, not patients”0:12:32 – Lessons learned & future trial directions https://www.hcplive.com/view/kidney-compass-iv-iron-and-functional-outcomes-in-kidney-transplant-recipients

    IV Iron and Functional Outcomes in Kidney Transplant Recipients
  2. 12/13/2025

    Phase 3 Data on Telitacicept in IgA Nephropathy at ASN Kidney Week 2025

    New phase 3 data released by Vor Bio underscore the potential of telitacicept, a dual BLyS/APRIL inhibitor, as a disease-modifying therapy for IgA nephropathy (IgAN), particularly for patients at high risk of progression.In this special edition episode of Kidney Compass: Navigating Clinical Trials, hosts Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS sit down with study investigators Jicheng Lv, MD, PhD, and Hong Zhang, MD, PhD, professors of internal medicine at Peking University First Hospital, following their presentation at the American Society of Nephrology (ASN) Kidney Week 2025.Telitacicept is a recombinant fusion protein designed to neutralize BLyS and APRIL, upstream drivers of B-cell survival and immunoglobulin class switching, including production of galactose-deficient IgA1, the pathogenic hallmark of IgAN. The 39-week multicenter, randomized, double-blind trial evaluated the agent’s impact on proteinuria, B-cell activity, immunoglobulin levels, and kidney function.In stage A, adults were randomly assigned 1:1 to telitacicept 240 mg subcutaneous weekly or placebo, in addition to background supportive care. The primary endpoint, which was defined as change in 24-hour urine protein-to-creatinine ratio (UPCR), was met with a −58.9% reduction in the telitacicept arm compared with −8.8% with placebo (P .0001). Week-39 data were consistent, with the treatment group showing a 55% 24-hour UPCR reduction.Clinically meaningful thresholds associated with improved long-term renal outcomes were achieved at substantially higher rates with telitacicept: 24h-UPCR 0.8 g/g: 61% vs 19.5% (placebo) 0.5 g/g: 42.1% vs 7.5% 0.3 g/g: 24.5% vs 0.6% Investigators highlighted kidney function remained stable across secondary endpoints. Mean eGFR change at week 39 was essentially unchanged with telitacicept (−0.010 mL/min/1.73 m²) compared with a modest decline in the placebo group (−0.77 mL/min/1.73 m²). Investigators also observed a lower risk of ≥30% eGFR decline (27%) with telitacicept versus placebo.Editor's Note: LV reports relevant disclosures with Chinook Therapeutics, KBP Bioscience, and others. Zhang reports no relevant disclosures.References: Lv, J, Liu LJ, Wang W, et al. Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study. Journal of the American Society of Nephrology. Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy | Vor Bio. Vor Bio. Published 2025. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-phase-3-clinical-study-0

  3. 11/13/2025

    Understanding Renal Outcomes in SURPASS-CVOT, With Sophia Zoungas, MBBS, PhD

    Welcome to Kidney Compass: Navigating Clinical Trials!In this special edition episode of Kidney Compass: Navigating Clinical Trials, host Brendon Neuen, MBBS, PhD, is joined by Sophia Zoungas, MBBS, PhD, an endocrinologist and head of the School of Public Health and Preventive Medicine at Monash University, to discuss a post hoc analysis of the phase 3 SURPASS-CVOT trial from American Society of Nephrology (ASN) Kidney Week 2025, which concluded tirzepatide (Mounjaro) significantly slowed kidney function decline and reduced albuminuria progression compared with dulaglutide (Trulicity) in patients with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD), and very high-risk chronic kidney disease (CKD).The analysis applied the KDIGO 2025 CKD risk classification, defining very high-risk CKD as eGFR 30 mL/min/1.73 m², or eGFR 30 to 45 mL/min/1.73 m² with micro/macroalbuminuria, or eGFR 45 to 60 mL/min/1.73 m² with macroalbuminuria.Among 1241 patients meeting these criteria, the mean age was 68.5 years, mean body mass index (BMI) was 33.0 kg/m², mean HbA1c was 8.5%, and mean diabetes duration was 19.2 years. SGLT2 inhibitor use at baseline was 24.9%.At 36 months, tirzepatide was associated with a significantly smaller decline in eGFR compared to dulaglutide: Change in eGFR: −3.0 (±0.5) mL/min/1.73 m² with tirzepatide vs −7.2 (±0.4) with dulaglutide (between-group difference: +4.1 mL/min/1.73 m²; P .001).Reductions in urinary albumin-to-creatinine ratio (UACR) also favored tirzepatide: Percent change in UACR: −45.6% with tirzepatide vs −28.0% with dulaglutide (between-group difference: −24.6%; P .001).The risk of the composite kidney outcome, which was defined as onset of macroalbuminuria, ≥50% eGFR decline, kidney failure, or kidney-related death, was 33% lower with tirzepatide (hazard ratio [HR], 0.67; 95% CI, 0.52 to 0.87; P = .002). Event rates were 16.7% (108/647) with tirzepatide and 23.0% (137/594) with dulaglutide. No new safety concerns were identified, and benefits were consistent regardless of baseline SGLT2 inhibitor use.Relevant disclosures for Neuen include AstraZeneca, Bayer, Boehringer and Ingelheim, Janssen, and others. Relevant disclosures for Zoungas include AstraZeneca, Boehringer Ingelheim, CSL Seqirus, Eli Lilly Australia, Moderna, MSD Australia, Sanofi and Novo Nordisk.References: Zoungas S, Nicholls S, Miller DL, Nishiyama H, Wiese RJ, D’Alessio DA. Tirzepatide vs. Dulaglutide Is Associated with Reduced Major Kidney Events in Patients with Type 2 Diabetes, CVD, and Very High-Risk Kidney Diseases. Presented at the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025. Eli Lilly and Company. Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease. July 31, 2025. Accessed July 31, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

    Understanding Renal Outcomes in SURPASS-CVOT, With Sophia Zoungas, MBBS, PhD

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About

Hosted by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, Kidney Compass: Navigating Clinical Trials is a regular podcast exploring and breaking down the latest updates and nuances of clinical trials in nephrology. By listening to Kidney Compass, you'll get the guidance you need to navigate the changing landscape of clinical trials across the spectrum of kidney disease.