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
August 26th, 2014
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

The POSEIDON Kidney Disease Registry and Biobank Save

Date Added
August 19th, 2014
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

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

Date Added
August 4th, 2014
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

Telomerase Immortalization of Principal Cells from Human Collecting Duct. Save

Date Added
June 30th, 2014
PRO Number
Pro00017363
Researcher
Phillip Bell
Keywords
Kidney
Summary

Patients with autosomal dominant polycystic kidney disease (ADPKD) have cysts in their kidneys. These balloon-like structures are lined with cells and we are very interested in understanding the derangement in the function of these cells that lead to cyst formation. In order to accomplish this, we need to isolate the cells that line the cyst structures and put them in a cell culture media. We will then use a procedure so that the cells will continue to grow in culture, indefinitely. We can then study the function of these cells to get more information on ADPKD.

Institution
MUSC
Recruitment Contact
Stacy Steele
843-876-2368
steeles@musc.edu

.Randomized Phase II Study Comparing Cabozantinib (NSC #761968 and IND #116059) with Commercially Supplied Sunitinib in Patients with Previously Untreated Metastatic Renal Cell Carcinoma Save

Date Added
June 17th, 2014
PRO Number
Pro00033913
Researcher
Harry Drabkin
Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for adult males and females with advanced or metastatic kidney cancer. Researchers want to find out what effects, good and/or bad, two study drugs called sunitinib and cabozantinib have on you and on advanced or metastatic kidney cancer. Sunitinib has been approved by the FDA and cabozantinib is an investigational drug. Both medications target special proteins that are on the surface of the kidney cancer cell and both drugs are taken by mouth.

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

The Impact of Human Papilloma Virus Vaccination in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients Save

Date Added
June 3rd, 2014
PRO Number
Pro00025387
Researcher
Katherine Twombley
Keywords
Kidney, Pediatrics, Transplant, Vaccine
Summary

The aim of the study is to determine the impact of the human papilloma virus (HPV) vaccination in Pediatric Chronic Kidney Disease, Dialysis, and Transplant Patients

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

A Phase II Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus Axitinib in Patients with Advanced Renal Cell Carcinoma Save

Date Added
May 13th, 2014
PRO Number
Pro00033034
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:

•To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
•To evaluate the safety of the study treatment in subjects with RCC.
•To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.

Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@musc.edu

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