Clinical Trials Logo

Clinical Trial Summary

The purpose of this research study is to learn if using statin in patients with nephrotic syndrome could lower the risk of blood clots. Nephrotic syndrome is a collection of signs and symptoms that occur when the glomeruli -the tiny filters that work in the kidney- leak protein in the urine.

One of the symptoms associated with nephrotic syndrome is hyperlipidemia: too much bad cholesterol (LDL). This bad cholesterol could be linked to the increased risk of blood clots in patients with nephrotic syndrome. The study doctors would like to see if taking a statin drug to reduce the amount of bad cholesterol could reduce the risk of blood clots.


Clinical Trial Description

Venous thromboembolic (VTE) events are common in the nephrotic syndrome (NS) occurring in up to 30% of patients when systematically screened. The investigator proposes to explore a novel mechanism for the increased clot formation in NS. To date, the only consistently identified underlying risk factor for VTEs is severe hypoalbuminemia related to the NS. The underlying pathophysiology related to VTE in NS remains poorly understood and has previously been ascribed to dysregulation of pro- and anticoagulant clotting factors due to urinary protein losses and reflected by the low serum albumin. However, the direct evidence for this mechanism is inconsistent and relatively poor. Another feature of NS is that of severe hyperlipidemia which also correlates with hypoalbuminemia. In other severely hyperlipidemic states (e.g. Familial Hypercholesterolemia), the level of oxidized low-density lipoprotein (oxLDL) is markedly elevated. Forms of oxidized LDL interact with monocytes and macrophages leading to expression of Tissue Factor (TF), a procoagulant molecule. Furthermore, monocytes and macrophages activated in this fashion also release microparticles, small cell-membrane derived vesicles, that also express TF and participate in initiating intravascular clot formation. the investigator hypothesizes that the hyperlipidemia of the nephrotic syndrome leads to elevations in oxidized LDL and in turn, elevations in microparticle Tissue Factor (MP-TF) and its activity. The investigator also hypothesizes that serum albumin levels will inversely correlate with hyperlipidemia as well as oxLDL levels and MP-TF activity. Here, the investigator will study the effect of treatment with HMGCoA reductase inhibitors (statins) on ox LDL and MP-TF activity patients with NS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01845428
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase Phase 1
Start date May 2012
Completion date January 2017

See also
  Status Clinical Trial Phase
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02927184 - Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease Phase 2
Completed NCT04640012 - Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects Phase 1
Completed NCT03213288 - Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status N/A
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02979704 - A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia Phase 2/Phase 3
Completed NCT02569814 - A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin Phase 1
Completed NCT02428998 - Safety for 24 Weeks Intake of Korean Red Ginseng in Adults N/A
Completed NCT02280590 - Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia Phase 4
Completed NCT01678183 - Financial Incentives for Medication Adherence N/A
Completed NCT01426412 - A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol Phase 1
Completed NCT01694446 - Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose N/A
Completed NCT01131832 - Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols Phase 4
Completed NCT00758303 - A Study to Evaluate the Lipid Regulating Effects of TRIA-662 Phase 2/Phase 3
Completed NCT00534105 - Lipid Metabolism in Gestational Diabetes N/A
Recruiting NCT00408824 - Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study) N/A
Completed NCT00362206 - Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin Phase 3
Terminated NCT00299169 - Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes Phase 4
Completed NCT00414986 - Using Learning Teams for Reflective Adaptation for Diabetes and Depression N/A
Completed NCT00381992 - Risk Assessment of Long-Haul Truck Drivers N/A