Role of Sphingolipids in the Development of Diabetic Nephropathy + save

Date Added
February 25th, 2014
PRO Number
Pro00032064
Researcher
Maria Lopes-virella
Keywords
Diabetes, Kidney
Summary

The purpose of this study is to investigate sphingolipids, a very biologically active class of lipids transported in lipoproteins, in patients with diabetes who have kidney disease (nephropathy). Lipoproteins are particles in blood which transport not only cholesterol and fats but also sphingolipids. Lipoproteins also play an important role in the development of diabetes complications, including nephropathy. This study will investigate the role of the sphingolipids in VLDL (Very Low Density Lipoprotein), LDL (Low Density Lipoprotein) and HDL (High Density Lipoprotein) in the development of nephropathy in diabetes.

Institution
MUSC
Recruitment Contact
Andrea Semler
843-789-6802
semleraj@musc.edu

An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the safety and efficacy of Docetaxel in combination with Ramucirumab (IMC-1121B) drug product or IMC-18F1 or without investigational therapy as second-line therapy in patients with locally advanced or metastatic transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis following disease progression on first-line platinum based therapy + save

Date Added
January 14th, 2014
PRO Number
Pro00011809
Researcher
Thomas Keane
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study will compare how bladder cancer responds to treatment with one of three regimens docetaxel, docetaxel with ramucirumab DP or docetaxel with IMC-18F1. The response to treatment will be measured by the length of time on assigned arm before the disease progresses. The study will also look at how long the tumor stays the same size, or in the event of a decrease in tumor size, how long the decrease in tumor size continues. The study will also look at the side effects of the chemotherapy arm compared with the side effects of chemotheapy combined with either investigational agent. The study will also gather information on the levels of ramucirumab DP or IMC-18F1 in the blood.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

Identification and characterization of “permeability factor” in blood of patients with proteinuric kidney diseases + save

Date Added
December 18th, 2013
PRO Number
Pro00018380
Researcher
Milos Budisavljevic
Keywords
Kidney
Summary

Overwhelming evidence exists that some types of proteinuric kidney diseases are causerd by factor(s) present in patients' blood. Identification and characterization of such factor(s) would greatly help in beter and noninvasive diagnosis of such conditions, development of better therapeutic options and potentially reveal underlying pathogenic mechanisms.
Owing to tremendous capabilities of proteomics facility within the Division of Nephrology we developed experiments that we think will result in significant improvement in our knoledge of major kidney diseases.

Institution
MUSC
Recruitment Contact
Milos Budisavljevic
(843) 792-4123
budisamn@musc.edu

A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy SONAR: Study of Diabetic Nephropathy with Atrasentan + save

Date Added
November 26th, 2013
PRO Number
Pro00029894
Researcher
Ruth Campbell
Keywords
Diabetes, Kidney
Summary

If you are an adult with type 2 diabetes mellitus and chronic kidney disease (diabetic nephropathy), you may be eligible to take part in a clinical research study called SONAR.
The purpose of this study is to find out if an investigational drug called atrasentan slows the progression of chronic kidney disease. Qualified participants will be randomly assigned to take either atrasentan by mouth or placebo (inactive pill). Study medication, study visits, blood work and study procedures will be provided free of charge.

Institution
MUSC
Recruitment Contact
Vickie Hunt
843-792-7852
huntv@musc.edu

The Use of the Newest Vital Sign and Short Health Literacy Survey in Identifying Health Literacy and Its Correlation to Nutritional Parameters among ESRD patients on Hemodialysis in Charleston, South Carolina + save

Date Added
November 16th, 2013
PRO Number
Pro00027798
Researcher
Rachel Sturdivant
Keywords
Kidney
Summary

End stage renal disease patients on dialysis will be screened and asked to participate in a health literacy survey during regular dialysis treatment days. Two health literacy survey tools will be used: The Newest Vital Sign which is a six-question nutritional label format health literacy tool and the Short Health Literacy Survey, a 3 question health literacy tool.
Nutritional and anthropometric parameters normally collected as part of the hemodialysis treatment will be obtained

Institution
MUSC
Recruitment Contact
Aileen Grace Cielo
843-792-4123
cielo@musc.edu

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of H.P. Acthar Gel (Acthar) in Treatment-Resistant Subjects with Persistent Proteinuria and Nephrotic Syndrome due to Idiopathic Membranous Nephropathy (iMN) + save

Date Added
October 8th, 2013
PRO Number
Pro00013639
Researcher
Milos Budisavljevic
Keywords
Kidney, Rare Diseases
Summary

This study is designed to see if the drug Acthar can help persons with proteinuria and nephrotic syndrome that is due to Idiopathic Membranous Nephropathy (iMN). Qualified participants will be randomly assigned to one of two treatment groups and will receive either injections of study drug or placebo (no drug in it). Participants will be taught how to safely give the injections to themselves at home and will learn how the dose is adjusted during the treatment period. The treatment period lasts 24 weeks and is followed by a 24 week observation period.

Institution
MUSC
Recruitment Contact
Caroline Counts
843 792 8980
counts@musc.edu

A prospective, pilot study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad(®) vaccination in pediatric patients less than two years of age + save

Date Added
October 1st, 2013
PRO Number
Pro00025854
Researcher
Katherine Twombley
Keywords
Kidney, Pediatrics, Transplant, Vaccine
Summary

The proposed study is a pilot study and a first step towards developing an optimized ProQuad vaccination strategy for children who are going to undergo a solid organ transplant. This strategy is unique and innovative as it will allow individualized recommendations for ProQuad vaccination earlier than the current recommended age in pre-transplant patients. This will potentially prevent many infectious complications in many children and allow them to have the same opportunity at the protective benefits of vaccination that are currently are afforded to them. If proven safe and effective, ProQuad vaccination will have an important positive impact, because it will protect a significant number of high-risk patients from developing life threatening, preventable infections.

Institution
MUSC
Recruitment Contact
Harvey Frampton
843-792-9454
frampton@musc.edu

The POSEIDON Kidney Disease Registry and Biobank + save

Date Added
September 17th, 2013
PRO Number
Pro00019764
Researcher
John M. Arthur
Keywords
Kidney, Rare Diseases, Transplant, Urinary
Summary

Currently, kidney disease affects up to 20% of the US population and is a strong contributor to morbidity and mortality in these patients. Specific therapies and diagnostic tools for kidney disease have been very slow to develop because of the absence of high quality samples and data that can be used for research studies. The purpose of this study is to develop a registry and sample bank called Poseidon (Prevention, Optimizing Safety, Early Intervention and DetectiOn in Nephrology) biobank that can be used for future research. In this study, patients can consent to donating their residual kidney tissue if they undergo a kidney biopsy and blood or urine during routine clinical care procedures. This study will allow biomedical research the ability to obtain specimens from patients with relevant diseases and appropriate clinical data. This study will collect patient demographic, clinical and historical data for a registry and patient samples will be deposited in the Poseidon biobank. Patients do not have to be diagnosed with Kidney Disease to be included in this study.

Institution
MUSC
Recruitment Contact
Elizabeth Shewfelt
8437926109
shewfelt@musc.edu

Lifestyle Improvements for Transplantation Success (LIFTS): Phase 1 Formative Analysis + save

Date Added
August 28th, 2013
PRO Number
Pro00027063
Researcher
John Sieverdes
Keywords
Exercise, Kidney, Nutrition, Obesity, Weight Control
Summary

A community and academic-based research program was formed between Donate Life SC and MUSC to investigate the familiarity, perceptions, and attitudes on how technology can be used to aid in a wellness program for dialysis patients who are on the transplantation wait list. This project is the first phase of a two phase study and will collect information from key informant interviews to gather these beliefs and attitudes with the intention of developing a wellness program that focuses on healthy eating and physical activity/strength training during a following phase of this project.

Institution
MUSC
Recruitment Contact
John Sieverdes
843-792-1235
sieverde@musc.edu

Physician Order for Scope of Treatment (POST): PILOT STUDY + save

Date Added
August 6th, 2013
PRO Number
Pro00022252
Researcher
Walter Limehouse
Keywords
Aging, Alzheimers, Cancer, Dementia, Ethnicity and Disease, Geriatrics, Heart, HIV / AIDS, Infectious Diseases, Kidney, Liver, Men's Health, Minorities, Nervous System, Pulmonary, Rare Diseases, Women's Health
Summary

South Carolina Coalition for Care of Serious Illness (SCC CSI) sponsors development of Physician Orders for Scope of Treatment (POST) in South Carolina. The SC POST follows the national POLST (www. polst.org) paradigm creating an advance treatment planning physician order that migrates as valid across institutional boundaries: from physician office, to home/nursing home/hospice to EMS to hospital emergency/inpatient services. The POST form encourages a conversation between a physician and the patient regarding treatment options available to seriously ill patients for whom death within a year would not be a surprise. These choices primarily include whether to attempt cardiopulmonary resuscitation in the event of cardiac or pulmonary arrest or not (a “DNR” or “Allow Natural Death” order) and whether during acute illness to provide full treatment including endotracheal intubation and intensive care, supportive treatment such as noninvasive ventilation and no intensive care, or comfort care only. The Charleston and Greenville areas will pilot POST. Investigators by area will survey providers completing POST documents for patients or treating patients with POST about the utility of this form and how use of the form affected their patient's treatment. A chart reviews of patients presenting with a POST form to a hospital emergency or inpatient unit will address whether providers respected patient treatment choices. SCC CSI plans to publish the results of the pilot in appropriate journals and present the results at medical meetings and to interested persons. The results of the study may provide the supporting documentation for subsequent legislation supporting POST. POST represents a coordinated statement of a seriously ill patient’s treatment choices to be honored across multiple treatment settings.

Institution
MUSC
Recruitment Contact
Walter Limehouse
792-9705
limehouw@musc.edu