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Nephrology-Hypertension Clinical Trials

The following searchable list includes all the Division of General Nephrology-Hypertension - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials

A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS

Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Borja-Cacho, DanielBorja-Cacho, Daniel
NCT01897688 STU00059469
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Chronic Kidney Disease Research Biorepository

The 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
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
STU00201546
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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.
Inclusion 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
Isakova, TamaraIsakova, Tamara
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
NCT02986984 STU00204808
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Evaluation of Renal Microvascular Perfusion by Contrast Enhanced Ultrasound

Contrast Enhanced Ultrasound Study:The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants …

Contrast Enhanced Ultrasound Study:

  • The study’s purpose is to measure blood flow to and from the kidney via contrast-enhanced ultrasound (contrast agent, Lumason®, is given via IV administration)
  • Participation consists of 5 study visits that are spread out over the course of 24 months (Healthy and ESRD participants only complete the first 2 study visits)
  • Study procedures consist of measuring height, weight, and vital signs, answering questions about demographics and medical history, a blood draw and urine collection at every visit, and undergoing the contrast-enhanced ultrasound (only at visit 2)
INCLUSION CRITERIA:
  • ≥ 18 years of age
  • Patient is able to provide written informed consent
  • Meet criteria for one of following patient populations:
  • CKD
  • eGFR ≥30 and <90 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation17 (with or without history of hypertension)
AND
  • Urine albumin to creatinine ratio (UACR) ≥ 30mg/g creatinine
OR
  • eGFR <30 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation (with or without history of hypertension AND with no UACR requirement)
  • ESRD
  • Currently receiving dialysis (hemodialysis or peritoneal dialysis)
  • No eGFR or UACR requirement
  • Healthy volunteer
  • No prior history of kidney disease (as defined by eGFR >60 ml/min/1.73m2 by CKD Epidemiology Collaboration (CKD EPI) equation and UACR <30 mg/g creatinine, based on Screening Visit lab results or average between local lab results (collected within 3 months from the date of the Screening Visit) and lab results from Screening Visit.
  • No self-reported history of hypertension, diabetes mellitus, liver disease, or cardiovascular disease

  • CKD-Biopsy
  • eGFR <90 ml/min/1.73m2 by CKD EPI equation
OR
  • Urine albumin to creatinine ratio (UACR) ≥30 mg/g creatinine
AND
  • Undergoing a clinically indicated renal biopsy
  • Transplant Kidney Biopsy
  • Kidney transplant recipient undergoing a protocol surveillance transplant kidney biopsy

EXCLUSION CRITERIA:

  • Known hypersensitivity to sulfur hexafluoride lipid or to any component of Lumason®
  • Known severe pulmonary hypertension (pulmonary artery pressure > 75mmHg)
  • Active cardiac disease including any of the following:
  • Unstable angina
  • Myocardial infarction within 48 hours prior to date of proposed Lumason® administration
  • Severe arrhythmia (ventricular tachycardia, uncontrolled atrial fibrillation with rapid ventricular response, torsades de pointes)
  • Escalating vasopressor requirements in prior 24 hours
  • Recent neurological compromise (i.e. cerebrovascular accident including transient ischemic attacks within 3 months of Lumason® administration)
  • Emergency cardiac surgery
  • BMI ≥ 35 kg/m2
  • Clinical signs of acute rejection as the indication for transplant kidney biopsy
  • Inability for patient or patient’s surrogate to provide informed consent
  • Pregnancy
  • Incarcerated individuals

Mehta, Rupal CMehta, Rupal C
  • Map it 633 N. St. Clair St.
    Chicago , IL
  • Map it 201 E. Huron St.
    Chicago, IL
STU00206894
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A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis

(ACTIVE, NOT RECRUITING) This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). 
Inclusion Criteria:
1. Primary FSGS
2. Male or Female aged 18-75 years
3. Urine protein/creatinine ratio ≥ 1.5 g/g
4. Estimated glomerular filtration rate (eGFR) ≥ 30
5. Blood pressure criteria: ≥100/60 mmHg and ≤160/100 mmHg
6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
Exclusion Criteria:
1. Secondary FSGS
2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
4. Body Mass Index (BMI) > 40
3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
Ghossein, CybeleGhossein, Cybele
NCT03493685 STU00206193
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Pathogenesis of Heart Failure with Preserved Ejection Fraction in Chronic Kidney Disease

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 …

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).

Inclusion 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.

Mehta, Rupal CMehta, Rupal C
STU00210997
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Cure Glomerulonephropathy

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.…

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.

Biopsy-proven Membranous, Minimal Change, FSGS, or IgAN within 5 years of study enrollment

Wadhwani, ShikhaWadhwani, Shikha
  • Map it 201 E. Huron St.
    Chicago, IL
STU00212470
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Immune checkpoint inhibitor-associated acute kidney injury

Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, …
Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer.  These medications have been demonstrated to have great promise for treating a variety of cancers.  However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal.  Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide.  We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors  of toxicity and best practices for management. 
Aggarwal, VikramAggarwal, Vikram
STU00212602
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RADIANCE Continued Access Protocol (RADIANCE CAP)

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.…

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Benzuly, Keith HBenzuly, Keith H
  • Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100
    Chicago, IL
NCT05017935 STU00216609
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