Active Studies

Matthew Weir

This Phase III, randomized, double-blind, event-driven trial evaluates the efficacy and safety of baxdrostat in combination with dapagliflozin versus dapagliflozin alone in patients with CKD and hypertension. The primary objective is to determine if adding this aldosterone synthase inhibitor to SGLT2i therapy reduces the risk of a composite endpoint including a ≥50% sustained decline in eGFR, kidney failure, or CV death. Participants not previously on an SGLT2i undergo a 4-week dapagliflozin run-in period prior to randomization. The study monitors long-term renal and cardiovascular outcomes through regular clinical assessments until a predetermined number of primary events occur.

Arsh Jain

This pragmatic, multicenter randomized controlled trial evaluates the efficacy of the VIEWER virtual care platform in patients with advanced CKD (Stage 5) or ESRD. The intervention integrates a mobile tablet application with wireless devices to monitor BP, weight, oxygen saturation, and step counts, alongside weekly ESAS-r symptom surveys. These data are transmitted to a provider portal where clinicians receive flags for out-of-range values to inform multidisciplinary care and volume management. The study's primary objective is to determine if this semi-continuous telemonitoring reduces the composite of ED visits and hospitalizations compared to usual care during the high-risk transition toward dialysis. Secondary outcomes include all-cause mortality, acute inpatient dialysis initiation, and patient-reported quality of life assessed by KDQOL-SF and PREM scores.

Christopher McIntyre

This pilot exploratory study evaluates cardiac sodium deposition across the spectrum of renal impairment using sodium and proton MRI. Investigators compare approximately 150 participants, including hemodialysis patients, patients with various stages of CKD, and age-matched healthy controls. The study correlates cardiac sodium content with biomarkers of cardiac stress, fluid volume measured by bioimpedance spectroscopy, and MRI-derived measures of cardiac function and fibrosis. The primary objective is to determine if myocardial sodium retention relates to cardiac structural abnormalities and to establish a baseline for future interventional studies.

Andrew House

The purpose of this study is the evaluate the clinical characteristics of adults with tuberous sclerosis complex and to provide multidisciplinary care.

Louise Moist

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in adults with CKD at risk of progression. Participants, with or without type 2 diabetes, are stabilized on an ACEi or ARB and empagliflozin before randomization to either BI 690517 or placebo. The primary objective is to assess the time to first occurrence of a composite clinical endpoint including worsening kidney disease, heart failure hospitalization, or cardiovascular death. Investigators monitor longitudinal changes in eGFR, UACR, and blood pressure over a follow-up period of approximately 3 to 4 years.

Christopher McIntyre

This prospective pilot study evaluates the utility of 23Na MRI in measuring kidney medullary sodium content to predict diuretic resistance in patients with chronic cardio-renal syndrome. Investigators compare baseline kidney sodium concentrations between patients with and without diuretic resistance and assess changes in sodium content following an intravenous dose of furosemide in the resistant cohort. Secondary measures include bioimpedance spectroscopy, NYHA classification, echocardiographic parameters, and 24-hour urine volume. The study aims to determine if 23Na MRI can quantify the intrarenal response to loop diuretics and guide precision dosing to overcome treatment failure.

Christopher McIntyre

This pilot exploratory study evaluates the use of 23Na MRI to quantify the renal corticomedullary sodium gradient in approximately 200 patients with CKD, nephrolithiasis, or ADPKD. Investigators utilize sodium-specific functional imaging to non-invasively measure medullary sodium concentration, a key determinant of urinary concentrating capacity. Clinical assessments include standardized blood pressure monitoring, serum labs, and spot UPCR/UACR, with 24-hour urine collections required for the nephrolithiasis cohort. The study aims to determine if alterations in the sodium gradient correlate with disease progression and to validate 23Na MRI as a functional biomarker for renal medullary health.

Louise Moist

OK-TRANSPLANT 2 is a pragmatic, open-label vanguard study evaluating the feasibility of a weight loss intervention for patients with obesity and high-risk CKD or ESKD seeking kidney transplantation. Participants are randomized to receive either a virtual weight management program, which includes semaglutide and coaching, or standard of care. The study assesses recruitment feasibility, treatment adherence over 26 weeks, and the safety profile of GLP-1RA therapy in this specific population. The primary objective is to determine the viability of a larger multicenter trial aimed at reducing BMI-related barriers to transplant waitlisting.

Pavel Roshanov

This Phase III, randomized, double-blind, active-controlled trial evaluates the efficacy of balcinrenone/dapagliflozin compared to dapagliflozin monotherapy in patients with chronic heart failure and impaired kidney function (eGFR 20-60) who are not taking an MRA (spironolactone, eplerenone, finerenone). Participants are randomized 1:1:1 to receive either 15 mg/10 mg balcinrenone/dapagliflozin, 40 mg/10 mg balcinrenone/dapagliflozin, or 10 mg dapagliflozin once daily. The primary objective is to assess the impact of these interventions on the risk of cardiovascular death and heart failure events, including those with and without hospitalization. This event-driven study monitors outcomes over an estimated 20-month blinded treatment period.

Arsh Jain

This Phase 3, randomized, double-blind, event-driven trial evaluates the efficacy of retatrutide in reducing major adverse cardiovascular events (MACE) and major adverse kidney events (MAKE). The study enrolls adults with a BMI ≥27 kg/m² who have established ASCVD, CKD, or both. Participants receive either subcutaneous retatrutide or placebo for approximately five years to assess long-term clinical outcomes. Primary endpoints focus on the incidence of serious cardiovascular complications and the progression of renal dysfunction. Secondary outcomes include changes in weight, eGFR, and UACR over the study period.

Matthew Weir

This Phase III, randomized, double-blind trial evaluates the efficacy and safety of baxdrostat, a selective aldosterone synthase inhibitor, in combination with dapagliflozin for patients with CKD and hypertension. The study population includes adults with CKD and high blood pressure who are either SGLT2i-naive or currently receiving SGLT2i therapy. Participants receive a 4-week dapagliflozin run-in period if treatment-naive, followed by a 24-month double-blind phase comparing baxdrostat/dapagliflozin to dapagliflozin plus placebo. The primary efficacy endpoint assesses CKD progression via changes in GFR following a 6-week open-label dapagliflozin washout period. Secondary outcomes focus on the long-term safety and tolerability of the combination regimen in this high-risk population.

Andrew House

This Phase III, randomized, multicentre, double-blind study evaluates the efficacy, safety, and tolerability of a zibotentan/dapagliflozin combination compared to dapagliflozin monotherapy. The study population includes patients with CKD and high proteinuria, specifically targeting those who remain at risk despite standard care. The primary objective is to determine if the addition of zibotentan, a selective endothelin A receptor antagonist, to the SGLT2 inhibitor dapagliflozin further reduces albuminuria. Researchers monitor changes in UACR and eGFR as key indicators of renal function and treatment response.