Compared to tacrolimus, obinutuzumab improved rates of complete and partial remission in patients with primary membranous nephropathy, while demonstrating comparable infection rates between the 2 treatment regimens.
Prof. Fernando Custodio Fervenza (Mayo Clinic, MN, USA) presented results from MAJESTY (NCT04629248), a phase 3, randomised, open-label, multicentre study comparing obinutuzumab with tacrolimus [1]. Patients were eligible if they had biopsy-confirmed membranous nephropathy, a 24-hour urine protein-to-creatinine ratio (UPCR) ≥5 g/g for 3 months or ≥4 g/g for 6 months despite receiving the best available therapy, and an estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73 m2. Patients were randomised 1:1 to receive obinutuzumab 1 g infusions at weeks 0, 2, 24, and 26, or to tacrolimus through week 60. The primary endpoint was complete remission at week 104, defined as UPCR ≤0.3 g/g with stable eGFR (no more than a 15% decline from baseline). A total of 142 patients were randomised.
The MAJESTY trial met its primary endpoint, with more patients receiving obinutuzumab than tacrolimus achieving complete remission at week 104. Furthermore, a greater proportion of patients receiving obinutuzumab achieved a proteinuric response at week 104. Obinutuzumab also resulted in higher rates of overall remission (complete or partial) at week 104 (51% vs 13%) and of complete remission at week 76 (36% vs 9%) compared with tacrolimus. Infections occurred in 61% of patients receiving obinutuzumab and 57% of those receiving tacrolimus, while serious infections occurred in 6% of patients in each group. Infusion-related reactions were reported in 38% of patients receiving obinutuzumab.
“In conclusion, obinutuzumab demonstrated superiority over tacrolimus in achieving complete remission at week 104,” concluded Prof. Fervenza. “Obinutuzumab also improved overall remission at week 104 and complete response at week 76, and no new safety signals were identified.”
- Fervenza FC, et al. Efficacy and safety of obinutuzumab compared with tacrolimus in primary membranous nephropathy: Topline results of the phase III MAJESTY trial. ERA 2026, 3–6 June. Glasgow, Scotland.
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Compared with placebo, rituximab prolonged remission by more than 2 years in patients with nephrotic syndrome due to minimal change disease or focal segmental glomerulosclerosis who responded to steroid treatment, according to clinical trial data reported by Dr Lisa Willcocks (Cambridge University Hospital, UK) and Prof. Megan Griffith (Imperial College London, UK) [1].
The TURING trial (EudraCT 2018-004611-50) was a phase 3, randomised, placebo-controlled trial evaluating rituximab in patients with nephrotic syndrome secondary to minimal change disease and focal segmental glomerulosclerosis. Patients were eligible if they had de novo or relapsing disease. At study entry, all patients received high-dose prednisolone until remission or for up to 16 weeks. Simultaneously, patients were randomised to receive either rituximab (1 g administered at weeks 0, 2, and 26) or matching placebo. Patients who did not achieve remission with prednisolone by week 16 were excluded from the primary analysis. The primary endpoint was the time from remission to relapse. Of the 149 patients enrolled, 122 achieved remission by week 16 and were included in the analysis.
Overall, 45 of 59 patients in the placebo group and 22 of 63 patients in the rituximab group relapsed. The median time to relapse was 22 weeks in the placebo group and was not reached in the rituximab group, corresponding to an HR of 0.22 in favour of rituximab (95% CI 0.13–0.37; P<0.0001). Subgroup analyses showed consistent results across groups defined by disease presentation (de novo vs relapsing disease), disease type (minimal change disease vs focal segmental glomerulosclerosis), prednisolone regimen, sex, ethnicity, and age at first presentation with nephrotic syndrome. Adverse events reported more frequently with rituximab included infusion-related reactions, infections, and hypogammaglobulinaemia.
“Three 1 g doses of rituximab can maintain remission for more than 2.8 years,” concluded Prof. Griffith. She added that “patients were exposed to high-doses of steroids during the trial, and we as a community need additional strategies to reduce glucocorticoid exposure in our patients.”
- Willcocks L, et al. The Use of Rituximab In the treatment of Nephrotic Glomerulonephritis (TURING): a multicentre, double-blind, randomised, placebo-controlled trial. ERA 2026, 3–6 June. Glasgow, Scotland.
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Compared with placebo, semaglutide significantly improved multiple quality-of-life measures in patients with type 2 diabetes and chronic kidney disease (CKD), according to data presented by Prof. Johannes Mann (Friedrich-Alexander University, Germany) [1].
FLOW (NCT03819153) was a phase 3, randomised, placebo-controlled trial that assigned patients with type 2 diabetes and concomitant CKD to once-weekly semaglutide plus standard of care or matching placebo plus standard of care. Patients were eligible if they had glycated haemoglobin (HbA1c) ≤10% and were receiving a renin–angiotensin–aldosterone system (RAAS) blocker. The primary endpoint, time to first occurrence of a kidney event, was met and had been previously reported. Patient-reported outcomes, assessed using the EuroQol-5-Dimensions, 5-Levels (EQ-5D-5L) questionnaire, were prespecified exploratory endpoints and were collected at baseline and annually throughout the trial.
After 104 weeks, semaglutide significantly improved scores compared with placebo in the mobility, self-care, usual activities, and pain/discomfort subdomains of the EQ-5D-5L questionnaire, but not in the anxiety/depression domain (p=0.55). Furthermore, the EQ-5D-5L visual analogue scale (VAS) score increased by 1.05 points with semaglutide and decreased by 1.10 points with placebo, corresponding to a between-group difference of 2.15 points (95% CI 1.15–3.15), indicating an improvement in overall quality of life. However, analysis of the EQ-5D-5L utility score showed no difference between treatment groups after 104 weeks.
“In adults with type 2 diabetes and CKD, semaglutide treatment, despite its known gastrointestinal effects, was associated with higher quality-of-life scores, corresponding to an estimated additional 8 days of full health per year,” concluded Prof. Mann. “The improvements in quality of life were observed across multiple domains, including mobility, self-care, usual activities and pain/discomfort.”
- Mann J, et al. The effects of semaglutide on health-related quality of life in adults with type 2 diabetes and chronic kidney disease: FLOW trial. ERA 2026, 3–6 June. Glasgow, Scotland.
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Crovalimab led to high response rates in adolescents and adults with atypical haemolytic uraemic syndrome (aHUS), while being associated with some serious infections, according to data reported by Dr Bradley Dixon (University of Colorado Anschutz, CO, USA) [1].
The COMMUTE-a (NCT04861259) phase 3 trial was the sister study of COMMUTE-p (NCT04958265) and had a similar study design. Briefly, patients were eligible if they were aged ≥12 years and had a body weight ≥40 kg. As in the paediatric study, 2 cohorts were enrolled: a treatment-naïve cohort (no prior complement inhibitor therapy) and a switch cohort. The primary endpoint was the proportion of patients achieving a complete thrombotic microangiopathy response (cTMAr) at any time through week 25, defined as a platelet count ≥ the lower limit of normal, normalisation of lactate dehydrogenase (LDH), and a ≥25% improvement in serum creatinine from baseline. A prespecified efficacy threshold of 40% was set for the primary endpoint. Each cohort included 41 patients.
The trial met its primary endpoint. In the treatment-naïve cohort, 59.5% of patients (95% CI 43.5%–73.7%) achieved cTMAr by week 25, with a median time to response of 12.1 weeks. Among the 17 patients who required dialysis at baseline, all had discontinued dialysis by week 25. In the switch cohort, all 41 patients maintained cTMAr through week 25, and all remained off dialysis. Overall, crovalimab was well tolerated. Serious infections were reported in 14.6% of patients in the treatment-naïve cohort and 17.1% of patients in the switch cohort. Transient immune complex reactions occurred in 9.8% of patients in the switch cohort, and all resolved within 2 weeks.
“The study met its primary endpoint, with 59.5% of treatment-naïve patients achieving cTMAr by the end of the primary analysis period,” concluded Dr Dixon. “All patients in the switch cohort met their efficacy endpoint of maintenance of cTMAr control. Together, these findings support a favourable benefit-risk profile for crovalimab, further reinforced by the results from COMMUTE-p.”
- Dixon B, et al. Efficacy, safety and pharmacokinetics/pharmacodynamics of crovalimab for atypical haemolytic uraemic syndrome (aHUS): Phase III COMMUTE-a trial. ERA 2026, 3–6 June. Glasgow, Scotland.
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Crovalimab led to high response rates in paediatric patients with atypical haemolytic uraemic syndrome (aHUS), while being associated with some infectious events.
Dr Maria Helena Vaisbich (University of São Paulo, Brazil) presented results from COMMUTE-p (NCT04958265), a phase 3 trial evaluating weight-based dosing of crovalimab in paediatric participants with aHUS [1]. Patients were eligible if they were aged 28 days to <18 years and had a body weight ≥5 kg. Two cohorts were enrolled: a treatment-naïve cohort (no prior complement inhibitor therapy) and a switch cohort (patients switching from eculizumab or ravulizumab). The primary endpoint was the proportion of patients achieving a complete thrombotic microangiopathy response (cTMAr) at any time through week 25, defined as a platelet count ≥ the lower limit of normal, normalisation of lactate dehydrogenase (LDH), and a ≥25% improvement in serum creatinine from baseline. Overall, 21 patients were included in the naïve cohort and 20 in the switch cohort.
In the naïve cohort, 70.6% of patients (95% CI 46.9%–86.7%) achieved cTMAr by week 25, with a median time to response of 8.7 weeks. Furthermore, all 6 patients who required dialysis at baseline had discontinued dialysis by week 25. In the switch cohort, 100% of patients maintained cTMAr through week 25, and none required dialysis. Serious infections were reported in 33.3% of patients in the naïve cohort and 20.0% of patients in the switch cohort. No deaths or transient immune complex reactions were reported.
“COMMUTE-p demonstrated a clinically meaningful cTMAr, and all treatment-naïve patients who required dialysis at baseline were off dialysis by week 25,” concluded Dr Vaisbich. “Patients in the switch cohort maintained cTMAr and also remained off dialysis. The study showed a favourable risk-benefit profile for crovalimab, supporting its use in paediatric patients with aHUS.”
- Vaisbich MH, et al. Efficacy, safety and pharmacokinetics/pharmacodynamics of crovalimab for paediatric atypical haemolytic uraemic syndrome: Phase III COMMUTE-p trial. ERA 2026, 3–6 June. Glasgow, Scotland.
Copyright ©2026 Medicom Education B.V.
Low-dose rivaroxaban did not improve cardiovascular outcomes in patients with advanced chronic kidney disease (CKD) compared with placebo, but was associated with an increased risk of major bleeding events.
Prof. Sunil Badve (University of New South Wales, Australia) presented results from TRACK (NCT03969953), a phase 3, investigator-initiated, multicentre, randomised, double-blind, placebo-controlled, multinational trial that evaluated low-dose rivaroxaban (2.5 mg twice daily) versus placebo in patients with advanced CKD [1]. Patients were eligible if they had stage 4 or 5, including those receiving dialysis, and were at high cardiovascular risk. Patients with bleeding disorders or at high risk of bleeding were excluded. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or a non-fatal peripheral artery disease event.
A total of 1,458 patients were randomised. However, the independent safety data monitoring committee recommended early termination of the trial because of “concerns about increased bleeding and a low probability of demonstrating efficacy,” said Prof. Badve. The primary outcome occurred in 20.7% of patients receiving placebo (11.8 events per 100 person-years) and in 22.6% of patients receiving rivaroxaban (13.0 events per 100 person-years; HR 1.09; 95% CI 0.87–1.36; P=0.46). Analysis of the individual components of the primary endpoint showed no benefit of rivaroxaban over placebo for any of the 4 outcomes. However, rivaroxaban significantly increased the incidence of major bleeding compared with placebo (5.1 vs 3.4 events per 100 patient-years; HR 1.51; 95% CI 1.02–2.22; P=0.04). The gastrointestinal tract was the most common site of major bleeding, and 6.3% of patients receiving low-dose rivaroxaban required hospitalisation due to bleeding compared with 4.7% of those receiving placebo.
“In patients with advanced CKD at high cardiovascular risk, low-dose rivaroxaban did not reduce the risk of the composite cardiovascular outcome,” concluded Prof. Badve. “Major bleeding events were significantly more frequent with low-dose rivaroxaban than with placebo.”
- Badve S, et al. Low-dose rivaroxaban in patients with advanced kidney disease and high cardiovascular risk: an international randomised, placebo-controlled trial. ERA 2026, 3–6 June. Glasgow, Scotland.
Copyright ©2026 Medicom Education B.V.
Nurandociguat, a soluble guanylate cyclase (sGC) activator, significantly improved urinary albumin-to-creatinine ratio (UACR) after 16 weeks of treatment compared with placebo, while increasing the incidence of hypotension and syncope.
Prof. Christoph Wanner (University Hospital of Würzburg, Germany) presented data from ALPINE 1 (NCT06522997), a phase 2b, prospective, randomised, controlled trial evaluating multiple dose levels of nurandociguat compared to placebo in patients with chronic kidney disease (CKD) [1]. Participants were eligible if they had an estimated glomerular filtration rate (eGFR) between 20 and 75 mL/min/1.73 m2, a UACR between 200 and 3500 mg/g, and were receiving the maximally tolerated labelled dose of standard-of-care therapy, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) plus sodium-glucose cotransporter 2 (SGLT2) inhibitors, finerenone, or glucagon-like peptide-1 receptor (GLP-1R) agonists. Patients with a systolic blood pressure of <100 mmHg or clinically relevant hypotension were excluded. The primary endpoint was the mean change in UACR at week 16. Overall, 751 patients were included.
A statistically significant reduction in UACR was observed with every nurandociguat dose compared with placebo (P<0.05). However, the minimum dose required to achieve a 30% improvement in UACR compared with placebo could not be determined. Treatment-emergent adverse events of special interest occurred more commonly with nurandociguat, including syncope, symptomatic hypotension, and worsening kidney function, with event rates increasing at higher dose levels.
“The study met its primary efficacy endpoint, demonstrating a statistically significant dose-response relationship,” concluded Prof. Wanner. “A statistically significant reduction in UACR was observed through week 16 across all dose groups. Nurandociguat was generally well tolerated, with a dose-dependent increase in treatment-related adverse events.”
- Wanner C, et al. Effect of nurandociguat on albuminuria in patients with CKD: A phase 2, randomized dose-finding clinical trial. ERA 2026, 3–6 June. Glasgow, Scotland.
Copyright ©2026 Medicom Education B.V.
Compared with placebo, finerenone slowed the decline in estimated glomerular filtration rate (eGFR) in patients with non-diabetic chronic kidney disease (CKD) due to glomerular disease.
Prof. Brendon Neuen (The George Institute for Global Health, Australia) presented a prespecified subgroup analysis of the phase 3 FIND-CKD trial (NCT05047263) in patients with CKD due to glomerular disease [1]. Of the overall FIND-CKD population, 57.0% had glomerular disease as the underlying cause of CKD, including 26.3% with immunoglobulin A (IgA) nephropathy, 13.6% with focal segmental glomerulosclerosis, 5.7% with membranous nephropathy, 1.6% with membranoproliferative glomerulonephritis, and 9.8% with other causes.
The eGFR curves in patients with glomerular disease showed a trend similar to that observed in the overall FIND-CKD population. In the placebo group, eGFR declined linearly, reaching an annualised decline of 4.2 mL/min/1.73 m2/year by month 36. In the finerenone group, eGFR showed an initial steep decline before stabilising, resulting in an annualised decline of 3.5 mL/min/1.73 m2/year by month 36, corresponding to a between-group difference of 0.7 mL/min/1.73 m2/year (95% CI 0.2–1.2). Furthermore, urinary albumin-to-creatinine ratio (UACR) decreased by 42% from baseline with finerenone, whereas it remained stable with placebo (0% change) at month 12, corresponding to a between-group difference of -42% (95% CI -48% to -35%). Regarding safety, finerenone demonstrated a profile in patients with glomerular diseases that was consistent with that observed in the overall FIND-CKD population.
“In this prespecified subgroup analysis from the FIND-CKD trial, finerenone compared with placebo slowed the annualised rate of eGFR decline and reduced albuminuria,” concluded Prof Neuen. “Finerenone was overall well-tolerated, with a safety profile consistent with that of the overall FIND-CKD population.”
- Neuen B, et al. Finerenone in patients with glomerulonephritis. ERA 2026, 3–6 June. Glasgow, Scotland.
Copyright ©2026 Medicom Education B.V.
Compared with placebo, finerenone slowed the decline of the annualised estimated glomerular filtration rate (eGFR) while increasing rates of hyperkalaemia in patients with non-diabetic chronic kidney disease (CKD), according to results reported by Prof. David Cherney (University of Toronto, Canada) and Prof. Hiddo J.L. Heerspink (University of Groningen, the Netherlands) [1].
FIND-CKD (NCT05047263) is a phase 3, randomised, double-blind, placebo-controlled trial assessing the effect of finerenone in patients with non-diabetic CKD. Patients were eligible if they were at risk of disease progression despite optimised angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy and were randomised 1:1 to receive either finerenone 10 mg once daily (eGFR ≥25 to <60 mL/min/1.73 m2), finerenone 20 mg once daily (eGFR ≥60 mL/min/1.73 m2), or placebo for a total treatment duration of 36 months. The primary endpoint was the mean annual rate of change in eGFR assessed as the total eGFR slope from baseline to month 32. Overall, 793 patients were included in the finerenone group and 791 in the placebo group.
Compared with placebo, finerenone significantly slowed eGFR decline, as demonstrated by the eGFR slope analysis. Subgroup analyses showed that the effect of finerenone on eGFR slope was consistent across subgroups defined by primary CKD cause (hypertension/ischemic nephropathy, chronic glomerulonephritis, and other), baseline eGFR, baseline urinary albumin-to-creatinine ratio (UACR; ≤1000 and >1000 mg/g), and concomitant sodium-glucose cotransporter 2 (SGLT2) inhibitor use. Finerenone also significantly reduced the risk of the composite kidney-cardiovascular endpoint (sustained ≥57% decrease in eGFR for >4 weeks, kidney failure, hospitalisation for heart failure, or cardiovascular death) compared with placebo (HR 0.77; 95% CI 0.60–0.99; P=0.043). Adverse events leading to discontinuation were more common with finerenone, whereas those leading to death were more common with placebo (1.3% vs 0.8%). Hyperkalaemia, a known class effect, was reported in 17.0% of patients receiving finerenone and 13.3% of those receiving placebo.
“This international, phase 3 clinical trial met its primary endpoint,” concluded Prof. Heerspink. “Finerenone reduced the mean annual rate in eGFR from baseline to month 32 and reduced the risk of the composite kidney-cardiovascular endpoint compared with placebo. Although there was a higher incidence of hyperkalaemia, the clinical impact was minimal.”
- Heerspink HJL, et al. Finerenone in patients with chronic kidney disease. ERA 2026, 3–6 June. Glasgow, Scotland.
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