Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2025
The soluble guanylate cyclase activator runcaciguat significantly improves albuminuria in patients with chronic kidney disease: a randomized placebo-controlled clinical trial.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04507061 (A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Individually Titrated Oral Doses of Runcaciguat in Subjects With Clinical Diagnosis of Chronic Kidney Disease With Diabetes and/or Hypertension and at Least One Cardiovascular Comorbidity), which is not on this map. Cited by 11 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Individually Titrated Oral Doses of Runcaciguat in Subjects With Clinical Diagnosis of Chronic Kidney Disease With Diabetes and/or Hypertension and at Least One Cardiovascular Comorbidity
Who cites it
11 citing papers in PubMed.
- Safety, pharmacokinetic, and pharmacodynamic characteristics of SK-08, a soluble guanylate cyclase activator, after oral administration in healthy participants: a randomized phase 1 trial.BMC nephrology · 2026Trial
- Novel Therapeutic Strategies for Patients With CKD and Diabetes Mellitus.Kidney international reports · 2026Review
- Next-generation therapeutics for diabetic kidney disease.Nature reviews. Nephrology · 2026Review
- The evolving field of nephrology: what comes next? A report from the European Renal Association Scientific Advisory Board.Clinical kidney journal · 2026Review
- Role of albumin in regulating platelet function.Frontiers in pharmacology · 2026Article
- Soluble guanylate cyclase modulators-a novel therapeutic approach for diabetic kidney disease.Renal failure · 2025Review
- Developments in albuminuria testing: A key biomarker for detection, prognosis and surveillance of kidney and cardiovascular disease-A practical update for clinicians.Diabetes, obesity & metabolism · 2025Review
- Diabetic Kidney Disease: From Pathophysiology to Regression of Albuminuria and Kidney Damage: Is It Possible?International journal of molecular sciences · 2025Review
- Influence of Soluble Guanylate Cyclase on Cardiac, Vascular, and Renal Structure and Function: A Physiopathological Insight.International journal of molecular sciences · 2025Review
- In the Era of Cardiovascular-Kidney-Metabolic Syndrome in Cardio-Oncology: From Pathogenesis to Prevention and Therapy.Cancers · 2025Review
- Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
background and hypothesisIn chronic kidney disease (CKD) the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathway is impaired. Runcaciguat, an sGC activator, activates heme-free sGC, restoring cGMP production. This phase 2a trial studied the efficacy, safety, and tolerability of runcaciguat in CKD patients with or without sodium-glucose co-transporter-2 inhibitor (SGLT2i).
methodsPatients with CKD and established atherosclerotic cardiovascular disease or heart failure, plus type 2 diabetes (T2D) and/or hypertension, were enrolled. All were receiving stable maximum tolerated renin-angiotensin system inhibitors with or without SGLT2i. They were randomized 3:1 to runcaciguat once daily, titrated weekly (30-120 mg if tolerated), or placebo for 8 weeks. The primary efficacy endpoint was urine albumin-to-creatinine ratio (UACR) (average of post-randomization Days 22, 29, and 57 vs baseline). CONCORD was separately powered for CKD and T2D with stable SGLT2i comedication, CKD and T2D without SGLT2i, and non-diabetic CKD.
resultsOf 243 patients randomized, 229 were included in the full analysis set (FAS) and 170 in the per-protocol set (PPS). In the PPS, UACR decreased by -45.2% versus placebo with runcaciguat in patients with CKD without SGLT2i (P < 0.001) and by -48.1% versus placebo in patients with CKD taking SGLT2i (P = 0.02) In the FAS, the relative reductions were -46.9% (P < 0.001) and -44.8% (P = 0.01), respectively. No significant difference was observed between patients with or without SGLT2i. In non-diabetic CKD, UACR was reduced versus baseline with runcaciguat, but the change was not statistically significant (P = 0.10). Serious treatment-emergent adverse events were reported in 7% of patients receiving runcaciguat and 8% receiving placebo.
conclusionRuncaciguat improved albuminuria in patients with CKD, irrespective of concomitant SGLT2i. Runcaciguat was well tolerated. sGC activation may represent a novel kidney-protective treatment in CKD patients (funded by Bayer AG; ClinicalTrials.gov number, NCT04507061).
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