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.
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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.
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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 |
Immune checkpoint inhibitor-associated acute kidney injurySince 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. IRB number STU00212602 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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A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous NephropathyThis is a phase 2/3 clinical trial looking at the safety and efficacy of the drug Zanubrutinib in Patients with biopsy proven Primary Membranous Nephropathy… This is a phase 2/3 clinical trial looking at the safety and efficacy of the drug Zanubrutinib in Patients with biopsy proven Primary Membranous Nephropathy Copy Study URL to Clipboard Copy |