Ongoing Studies
CARSK: Canadian Australian Randomized Trial of Screening Kidney Transplant Candidates for Coronary Artery Disease
Cardiovascular disease is known to be the most common cause of death in end stage renal disease patients on the transplant waiting list and after kidney transplant. The current standard of care is to screen for coronary artery disease prior to entering waitlist for kidney transplant and then every one to two years. This study aims to prevent premature cardiovascular mortality immediately during the post-transplant period. However, there is growing evidence of increased harm from CAD screening in this patient population. CARSK study hypothesizes that after screening for wait list entry, no further screening for CAD is non-inferior to the current standard of care.
APOLLO: APOL1 Long Term Kidney Transplantation Outcome Networks
APPOLO is an observational prospective study on recipients of kidneys transplanted from living and deceased donors who possess two APOL1 renal risk variants (high-risk genotypes). The study aims to determine whether patients with APOL1 renal risk variants have shorter time to death-censored renal allograft failure than those who do not possess the high-risk genotypes. Determination of rates of change in allograft kidney function, development of overt proteinuria and renal outcomes will be sought. Findings will contribute to cost-effectiveness of utilization of kidneys from deceased and living donors with recent African ancestry, reduce ethnic disparities in renal outcomes and improvement of evaluation, selection and counseling of potential kidney donor candidates with recent African ancestry.
Hemodialysis Novel Therapies Consortium
In 2013, the National Institute of Diabetes, Digestive and Kidney diseases established the Hemodialysis Novel Therapies consortium to pilot novel, high risk and high reward therapies to improve outcome in end-stage renal disease patients. The consortium members include George Washington University, Harvard University, University of Pennsylvania, University of Washington and Vanderbilt University. Ongoing studies include under the umbrella of this consortium include
TarGut (Microbiome) ESRD studies
Gut microbiome is altered in patients with kidney disease and is an important source for uremic toxins. The principal aims of this study will determine the clinical utility of modulating gut microbiome to reduce uremic toxicity and attenuate inflammation using prebiotic and other novel approaches. The microbiome will be characterized using 16s sequencing and the metabolic response assessed using targeted and untargeted metabolomics approaches. Dr. Raj is the lead investigator in this project.
Safety and Cardiovascular Efficacy of Spironolactine in Dialysis-Dependent ESRD (SPin-D) Trial
Both experimental and clinical data strongly implicate aldosterone homeostasis in ESRD-associated CVD, providing a compelling rationale for assessing the safety, tolerability and therapeutic potential of aldosterone blockade using spironolactone to improve cardiovascular outcomes and overall mortality in the setting of dialysis-dependent ESRD. This study will examine the safety of spironolactone and also will examine its effect on cardiac geometry and reducing the risk for arrhythmia. This study will provide critical preliminary data needed to choose an optimal dose of spironolactone in the dialysis population and to design large-scale trials testing whether spironolactone can effectively improve the poor cardiovascular outcomes in dialysis-dependent ESRD.
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) study
The goal of this study is to evaluate the safety and tolerability of the interleukin‐1β receptor antagonist, anakinra, for patients receiving maintenance hemodialysis during a 24-week treatment period and a 24 week post‐treatment period. We will also assess the efficacy of anakinra for reducing inflammation during 24 weeks of treatment for patients receiving maintenance hemodialysis 3. To explore the effects of anakinra on markers of inflammation, cardiovascular risk, nutrition and metabolism, and patient reported outcomes for patients receiving maintenance hemodialysis.
Pilot Studies in Chronic kidney disease consortium
NIDDK established by NIDDK in 2013 with the goal of testing novel interventions in CKD that are likely to slow the progression of CKD and decrease cardiovascular disease burden. The consortium consists of the George Washington University, University of California at San Diego, Northwestern University and University of Utah with Cleveland Clinic serving as the Data Coordinating Center.
TarGut (Microbiome) CKD study
The goal of this study is to characterize the diversity and variability of gut microbiome of individuals with CKD and to explore the effects of p-inulin on the gut microbiome profile. Metabolic consequences of microbiome and the intervention will be studied using targeted and untargeted metabolomic approaches. GWU is the lead site for this research.
Bicarbonate Administration to Stabilize eGFR (BASE) Study
The BASE study is a four-arm randomized, double-blind, placebo-controlled pilot study to determine the feasibility, in terms of safety and tolerability, of prescribing one to two doses of oral sodium bicarbonate (0.5 or 0.8 mEq/kg-LBW/day). We will also test whether this intervention slows the progression of CKD in patients with moderate-severe CKD and normal serum bicarbonate concentration.
The CKD Optimal Management with Binders and NicotinamidE (COMBINE) study
The COMBINE clinical trial is a four-arm randomized, double blind, placebo-controlled pilot study evaluating the effects of nicotinamide and lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients with Chronic Kidney Disease (CKD) stages 3-4. We will also be looking at safety and tolerability of the study medications. Patients are in the study for 12 months and take study medication for 12 months.
Prebiotics in Peritoneal Dialysis
The goal of this non-randomized, open label, three period crossover trial, is to characterize the gut microbiome of individuals with ESRD treated with peritoneal dialysis and to explore the effects of p-inulin on the gut microbiome. This study is supported by the National Kidney Foundation and by the University of Florida Metabolomic Core. Maria Wing PhD is the lead investigator for this study, she will work under the mentorship of Dr. Raj
Systolic Blood Pressure Intervention Trial (SPRINT) Study
The SPRINT study examined the effect of intensive vs. standard therapy on blood pressure control in subjects with high risk for cardiovascular disease. The primary aim of the study is reduction in cardiovascular events. It is also examining the effect of blood pressure control on renal end points and neurocognitive function. The study showed that intensive treatment of blood pressure is beneficial in reducing cardiovascular events and death. Analysis of secondary outcomes are ongoing.
Chronic Renal Insufficiency Cohort (CRIC) study
We are looking at the cause and consequence of inflammation in CKD patients using genetic and biomarker approach in CRIC study. The primary focus to understand the role of inflammation in progression of CKD and cardiovascular disease in CKD.
Role of microRNAs in kidney disease
MicroRNAs (miRNA) are small non-coding RNAs that exert post-transcriptional control of gene expression. Identification of specific miRNA pathways for the progression of CKD and its complications will enhance diagnosis, risk stratification and implement hypothesis driven targeted interventions. We are piloting studies that are aimed at examining the role of miRNA in progression of CKD and atherosclerosis.
Cardiac Arrhythmia Monitoring and Related Outcomes in End Stage Renal Disease Patients (CAMARO-ESRD) study:
Sudden cardiac death is common in dialysis patients. This National Heart Blood Lung Institute funded study will continuously monitor heart rhythm in hemodialysis patients using an miniatured implanted devise for about three years. Findings from this study will identify the prevalence and cause and type of arrhythmia in patient on dialysis and lead to preventive therapies. The study will be performed in three institutions, Johns Hopkins University (lead institution), University of Maryland and George Washington University.