PodcastyMedycynaKidney Compass: Navigating Clinical Trials

Kidney Compass: Navigating Clinical Trials

Kidney Compass: Navigating Clinical Trials
Kidney Compass: Navigating Clinical Trials
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20 odcinków

  • Kidney Compass: Navigating Clinical Trials

    REMODEL Trial Provides Mechanistic Rationale for Semaglutide in CKD

    14.04.2026 | 14 min.
    At the World Congress of Nephrology 2026 in Yokohama, Japan, growing attention is being paid not just to whether therapies improve outcomes in chronic kidney disease, but how they work at a mechanistic level.
    In this episode of Kidney Compass, host Brendon Neuen, MBBS, PhD, spoke with David Cherney, MD, PhD, about the REMODEL trial, a mechanistic study designed to better understand the kidney-protective effects of semaglutide in patients with type 2 diabetes and chronic kidney disease.
    0:00:00 – Episode intro & guest setup
    0:00:54 – What is REMODEL & link to FLOW
    0:01:21 – Design, outcomes & mechanistic readouts of REMODEL
    0:04:30 – Additive effects with SGLT2 inhibitors
    0:07:17 – Perirenal fat, venous pressure & “toxic adiposity”
    0:10:28 – Relevance to non‑diabetic CKD & SMART trial link
    0:13:20 – Clinical messaging & patient communication
    https://www.hcplive.com/view/kidney-compass-remodel-trial-provides-mechanistic-rationale-for-semaglutide-in-ckd
  • Kidney Compass: Navigating Clinical Trials

    IV Iron and Functional Outcomes in Kidney Transplant Recipients

    14.04.2026 | 17 min.
    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 framing
    0:01:11 – Rationale & observational signals
    0:03:03 – Choice of primary endpoint (6‑minute walk)
    0:04:35 – Trial design & blinding details
    0:05:11 – Inclusion criteria & population profile
    0:07:48 – Dosing regimen & primary outcome result
    0:09:03 – 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
  • Kidney Compass: Navigating Clinical Trials

    New 2-Year APPLAUSE-IgAN Data for Iptacopan at WCN 2026

    14.04.2026 | 19 min.
    The treatment landscape for IgA nephropathy (IgAN) continues to evolve at a rapid pace, and new data presented at the World Congress of Nephrology (WCN) in Yokohama, Japan, suggest a potential shift in how clinicians approach disease modification in high-risk patients.
    In this episode of Kidney Compass, hosts Shikha Wadhwani, MD, MS, and Brendon Neuen, MBBS, PhD, spoke with Vlado Perkovic, MBBS, PhD, about newly presented 2-year eGFR slope data from the phase 3 APPLAUSE-IgAN trial evaluating iptacopan.
    0:00:00 – Episode intro & trial topic
    0:00:52 – Overview of APPLAUSE trial & headline efficacy
    0:02:40 – Hard outcome composite & safety profile
    0:04:21 – Positioning iptacopan in guidelines & background therapy
    0:05:10 – Consistency across subgroups & need for biomarkers
    0:07:37 – Acute vs chronic eGFR slope with immunologic therapies
    0:11:29 – Rationale for combination immunologic therapy
    0:13:01 – Magnitude of effect, residual risk & early diagnosis
    https://www.hcplive.com/view/kidney-compass-new-2-year-applause-igan-data-for-iptacopan-at-wcn-2026
  • Kidney Compass: Navigating Clinical Trials

    ASSIST Trial Shows Atrasentan Benefit on Top of SGLT2 Inhibitors

    14.04.2026 | 12 min.
    As the treatment landscape for IgA nephropathy grows increasingly complex, new data presented at the World Congress of Nephrology 2026 in Yokohama, Japan, are beginning to clarify how emerging therapies may work together.
    In this episode of Kidney Compass, hosts Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, sat down with Hiddo Heerspink, PhD, PharmD, to discuss the phase 2 ASSIST trial, which evaluated the efficacy and safety of atrasentan in combination with SGLT2 inhibitors.
    0:00:00 – Episode introduction & trial focus
    0:00:40 – Rationale & design of ASSIST
    0:02:04 – Detailed crossover structure
    0:02:59 – Inclusion of lower proteinuria patients
    0:04:20 – Relationship to ALIGN trial
    0:05:42 – Main efficacy & safety findings
    0:08:43 – Role of crossover studies & individual response
    0:10:37 – Future sequencing of therapies
    https://www.hcplive.com/view/kidney-compass-assist-trial-shows-atrasentan-benefit-on-top-of-sglt2-inhibitors
  • Kidney Compass: Navigating Clinical Trials

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

    13.12.2025 | 17 min.
    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
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O 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.
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