Clinical Trials
As part of an academic medical center, the Department of Medicine at Northwestern University Feinberg School of Medicine aims to improve the human health through scientific research.
About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.
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Department of Medicine Clinical Trials
The following searchable list includes all Division of Division of Nephrology and Hypertension, Department of Medicine clinical trials currently looking for participants.
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Chronic Kidney Disease Research BiorepositoryThe objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research Copy Study URL to Clipboard Copy |
Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that … This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol. Eligibility CriteriaInclusion Criteria • Type 1 and 2 Diabetes by ADA criteria (see appendix ) • Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site • Able to provide informed consent • Adult participants (no age restriction) • Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist Exclusion Criteria • ESRD, defined as chronic dialysis or kidney transplant • History of receiving dialysis for more than 30 days • Institutionalized • Solid organ or bone marrow transplant recipient at time of first kidney biopsy • Less than 3-year life expectancy • Known alcohol or substance abuse • Unable to provide informed consent • No evidence of active cancer other than non-melanoma skin cancer Copy Study URL to Clipboard Copy |
Pathogenesis of Heart Failure with Preserved Ejection Fraction in Chronic Kidney DiseaseHeart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes.Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early … Heart failure (HF) and chronic kidney disease (CKD) commonly coexist and increase risks of hospitalizations and mortality. Insights into mechanisms of concurrent HF and CKD are urgently needed to improve outcomes. Critical barriers to therapeutic breakthroughs for patients with CKD and HF include lack of in-depth understanding of early changes in cardiac function and poor knowledge of CKD-specific mechanisms for both HF and heart failure with preserved ejection fraction (HFpEF). Eligibility CriteriaInclusion Criteria: Inclusion criteria for all: >18 years of age Inclusion criteria for CKD: eGFR 20-60 ml/min/1.73m2 on stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker, unless contraindicated. Inclusion criteria for the non-CKD group: eGFR >60 ml/min/1.73m2 and UACR <30 mg/g. Exclusion Criteria: Exclusion criteria for all: presence or history of diabetes, coronary revascularization within the last 6 months, hemodynamically significant valvular disease, significant lung disease requiring home oxygen, angina, non-revascularized myocardial ischemia, systolic BP <100 or >180 mmHg, pregnancy, clinical HF symptoms, history of systemic disease processes that can cause HFpEF, such as amyloidosis or sarcoidosis, any musculoskeletal or chronic condition that will interfere with completion of cardiac testing, or active cancer, immunosuppressive therapy. Participants will also be excluded from continuing in the study if the pre-exercise echocardiogram demonstrates a reduced ejection fraction ≤50% or hemodynamically significant valvular disease at the baseline study visit. Exclusion criteria for the non-CKD group: eGFR <60 ml/min/1.73m2 and UACR >30 mg/ Exclusion criteria for CKD: currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy, SGLT2i hypersensitivity, liver disease, ALT/AST> 3x normal, history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months. IRB number STU00210997 Copy Study URL to Clipboard Copy |
Cure GlomerulonephropathyCure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention.… Cure Glomerulonephropathy (CureGN) is an NIH-sponsored cohort study of patients with biopsy-proven glomerular disease. Participants will be followed longitudinally with annual blood/urine collection to better understand the causes of disease, response to therapy, and disease progression. There is no study drug/intervention. Copy Study URL to Clipboard Copy |
A Phase 2b/3, Multi-part,Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN)The purpose of this study is to learn about the effects of study medication on decreasing damage to the kidneys and find the most effective dose for treating IgAN, and to see how safe the study drug is for patients with IgAN. The study will compare the effects of the … The purpose of this study is to learn about the effects of study medication on decreasing damage to the kidneys and find the most effective dose for treating IgAN, and to see how safe the study drug is for patients with IgAN. The study will compare the effects of the study medicine, which is given by injection, with placebo injections to find out if the study drug helps treat IgAN. Eligibility Criteria -Diagnosed with IgAN, as demonstrated by renal biopsy conducted within the past 10 years -Urine protein excretion >1g/24 hours, or UPCR >1.0mg/mg based on 24 hour urine collection -Stable dose of RAASi for 12 weeks at screening -Blood pressure <150/90 -eGFR >30 mL/min/1.73m2 Location(s)
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Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney DiseaseThe purpose of this study is to better understand the effects of dapagliflozin versus standard of care on heart function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with kidney disease. Dapagliflozin is in a class of drugs called sodium … The purpose of this study is to better understand the effects of dapagliflozin versus standard of care on heart function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with kidney disease. Dapagliflozin is in a class of drugs called sodium glucose cotransporter 2 inhibitors (SGLT2i). SGLT2i acts on the kidney and blocks sodium and glucose reabsorption in the kidney. SGLT2i have shown to improve both kidney outcomes, such as drops in kidney function and need for dialysis, as well as heart outcomes, such as heart attacks, chest pain, or need for heart surgery in patients with and without kidney disease Eligibility Criteria Inclusion criteria for all: >18 years of age, eGFR 25-60 ml/min/1.73m2 on stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker, unless contraindicated, [must meet 3 out of the following 5 criteria: septal e' < 7 cm/sec, lateral e’ < 10 cm/sec, average E/e' ratio > 14, LA volume index >34 mL/m2, Peak TR velocity > 2.8 m/sec], peak VO2 Females: ≤ 18 mL/kg/min, peak VO2 Males: ≤ 20 mL/kg/min, left ventricular longitudinal strain (LVLS) <18%, left atrial reservoir strain (LARS) <25% on 2d speckle tracking echocardiography, and lack of augmentation of LVLS or LARS during exercise. Exclusion criteria for all: presence of Type 1 Diabetes Mellitus, coronary revascularization within the last 6 months, hemodynamically significant valvular disease, significant lung disease requiring home oxygen, angina, non-revascularized myocardial ischemia, symptomatic (dizziness, lightheadedness or per discretion of the PI) systolic BP <100 or >180 mmHg, pregnancy, clinical HF symptoms, history of systemic disease processes that can cause HFpEF, such as amyloidosis or sarcoidosis, any musculoskeletal or chronic condition that will interfere with completion of cardiac testing, or active cancer, immunosuppressive therapy. Participants will also be excluded from continuing in the study if the baseline or pre-exercise echocardiogram evaluated by the sonographer demonstrates a reduced ejection fraction <50%, no evidence of subclinical HFpEF or hemodynamically significant valvular disease at the baseline study visit, currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy, SGLT2i hypersensitivity, liver disease, ALT/AST> 3x normal, Polycystic Kidney Disease, history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months. Keywords Chronic Kidney Disease Copy Study URL to Clipboard Copy |
A parallel-group treatment, Phase 2a, multicenter, randomized, double-blind, placebo-controlled umbrella study to evaluate the efficacy and safety of frexalimab, brivekimig, and rilzabrutinib in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)The purpose of this research is to see how safe and effective three investigational study drugs are at reducing damage to the cells in the kidney, decrease the amount of protein that leaks into the urine and improve symptoms in subjects diagnosed with primary focal segmental glomerulosclerosis or minimal change … The purpose of this research is to see how safe and effective three investigational study drugs are at reducing damage to the cells in the kidney, decrease the amount of protein that leaks into the urine and improve symptoms in subjects diagnosed with primary focal segmental glomerulosclerosis or minimal change kidney disease. Copy Study URL to Clipboard Copy |