CLINICAL TRIALS

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Project TitleMetabolic Effects of Paricalcitol
StatusOngoing, but not recruiting participants
Principal InvestigatorIan de Boer
CTINCT01003275    View on ClinicalTrials.gov
Patient PopulationStage 3-4 chronic kidney disease     InterventionsDrug: Paricalcitol; Drug: Placebo     Enrollment20    
Funding AgencyAbbott
HypothesisThe purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Project TitleRandomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
StatusCompleted
Principal InvestigatorIan de Boer
CTINCT00552409    View on ClinicalTrials.gov
Patient Populationtype 2 diabetes and stage 1-2 chronic kidney disease     InterventionsDietary Supplement: Cholecalciferol; Dietary Supplement: Placebo     Enrollment40    
Funding AgencyUniversity of Washington Institute for Translational Health Science (KL2), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/National Institutes of Health
HypothesisThis study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease.
Project TitleRandomized clinical trial of vitamin D3 and omega-3 fatty acids for diabetic kidney disease (VITAL Diabetes)
StatusActive
Principal InvestigatorIan de Boer
Patient Population     Interventions     Enrollment    
Funding Agency
HypothesisThe focus of this trial is to test in a large, well-powered, broadly representative randomized clinical trial whether vitamin D3 (cholecalciferol) and/or omega-3 fatty acid supplements prevent the development and progression of diabetic kidney disease. This is an ancillary study to the large NIH-funded Vitamin D and Omega-3 Trial (VITAL). The anticipated impact will be to determine whether vitamin D3 and/or omega-3 fatty acid supplementation can prevent the development and progression of kidney disease in the large and growing diabetes population.
Project TitleSUGAR: Study of glucose and insulin in renal disease
StatusPending
Principal InvestigatorIan de Boer
Patient Population     Interventions     Enrollment    
Funding Agency
HypothesisThe focus of this study is to define insulin sensitivity, pancreatic beta-cell function, and glucose tolerance in nondiabetic stage 3-4 chronic kidney disease, and to validate simple methods to ascertain these functions. Anticipated impact is to determine whether insulin resistance and/or beta-cell function are therapeutic targets for cardiovascular disease prevention in chronic kidney disease by building a foundation of physiology knowledge and methods to ascertain these processes in future epidemiology studies and clinical trials.
Project TitleSafety and Tolerability of Coenzyme Q10 in Hemodialysis Patients
StatusCompleted
Principal InvestigatorJonathan Himmelfarb
CTINCT00908297    View on ClinicalTrials.gov
Patient Populationend-stage renal disease receiving thrice weekly hemodialysis     InterventionsDietary Supplement: Coenzyme Q10     Enrollment20    
Funding AgencyNational Center for Complementary and Alternative Medicine (NCCAM)/National Institutes of Health
HypothesisThe purpose of this study is to determine the safety and tolerability of the dietary supplement Coenzyme Q10 in hemodialysis patients.
Project TitlePomegranate and Hemodialysis Pilot Trial (POM Pilot)
StatusCurrently recruiting
Principal InvestigatorJonathan Himmelfarb
CTINCT01562340    View on ClinicalTrials.gov
Patient Populationend-stage renal disease receiving thrice weekly hemodialysis     InterventionsOther: pomegranate juice; Other: Pomegranate fruit extract      Enrollment30    
Funding AgencyPOM Wonderful
HypothesisIn this study, pomegranate juice or fruit extract will be administered as a targeted antioxidant therapy to hemodialysis patients. We will examine whether these pomegranate products will be safe and well-tolerated. The investigators will also examine whether these products may lead to improvements in blood serum biomarkers of:
Project TitleGenes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3 (Primary, Vanderbilt University)
StatusCurrently recruiting
Principal InvestigatorJonathan Himmelfarb
CTINCT00878969    View on ClinicalTrials.gov
Patient Populationthrice weekly chronic hemodialysis for at least 6 months     InterventionsDrug: ramipril (ACE inhibitor) Drug: valsartan (ARB) Drug: Placebo     Enrollment210    
Funding AgencyNational Institutes of Health, Vanderbilt University
HypothesisThe purpose of the study is to test the hypothesis that angiotensin-converting enzyme inhibition and angiotensin receptor blockade differ in their long term effects on biomarkers of fibrinolysis, oxidative stress,inflammation and on carotid intima-media thickness (IMT), a predictor of cardiovascular events, in patients with chronic kidney disease undergoing maintenance hemodialysis.
Project TitleOxidative Stress in Chronic Kidney Disease: Diet and Exercise (Primary, Vanderbilt University)
StatusCurrently recruiting
Principal InvestigatorJonathan Himmelfarb
CTINCT01150851    View on ClinicalTrials.gov
Patient PopulationStage III-IV CKD measured by the MDRD equation with eGFR 15-60 ml/min/1.73m2;     InterventionsOther: caloric restriction Other: aerobic exercise     Enrollment144    
Funding AgencyNational Institutes of Health, Vanderbilt University
HypothesisThe central aim of this study is to improve the understanding of how metabolic pathways that contribute to adiposity also amplify risks of kidney disease progression and cardiovascular disease in subjects with moderate to severe CKD. We hypothesize that implementation of caloric restriction and aerobic exercise is feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to severe CKD.
Project TitleSeattle Cardiorenal Remote Ischemic Preconditioning Trial (SCRIPT)
StatusCurrently recruiting
Principal InvestigatorChristine Hsu
CTINCT01260259    View on ClinicalTrials.gov
Patient Populationchildren undergoing cardiac surgery and cardiopulmonary bypass (CPB)     InterventionsProcedure: RIPC Procedure: Control     Enrollment100    
Funding AgencySeattle Children's Hospital
HypothesisRemote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.
Project TitleA Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis
Statusnot yet open for participant recruitment
Principal InvestigatorBessie Young
CTINCT01576887    View on ClinicalTrials.gov
Patient PopulationESRD and been on PD for longer than 3 months     InterventionsDrug: Placebo (Oral, once daily) Experimental: Bardoxolone Methyl Drug: Bardoxolone Methyl 20 mg (Oral, once daily)      Enrollment45    
Funding AgencyReata Pharmaceuticals, Inc.
HypothesisThis study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
Project TitleNephrotic Syndrome Study Network (Primary, University of Michigan)
StatusCurrently recruiting
Principal InvestigatorPeter J. Nelson
CTINCT01240564    View on ClinicalTrials.gov
Patient PopulationPediatric and adults patients with focal segmental glomerulosclerosis, minimal change disease, or membranous nephropathy     Interventionsnone     Enrollment450    
Funding AgencyNIDDK and ORD, NIH
HypothesisThe purpose of this observation study is to collect and integrate high fidelity clinical, pathologic, and molecular phenotypes from patients to identify targetable disease pathways and new biomarkers of progression and remission of nephrotic glomerular diseases.
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