Clinical Trials

IRB number STU00201546

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

ClinicalTrials.gov IdentifierNCT02986984IRB number STU00204808

Eligibility CriteriaINCLUSION 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

IRB number STU00206894

Eligibility CriteriaInclusion 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.

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.

Eligibility Criteria

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

IRB number STU00212470

ClinicalTrials.gov IdentifierNCT05017935IRB number STU00216609