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
April 14th, 2015
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 12th, 2015
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

A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features Save

Date Added
January 20th, 2015
PRO Number
Pro00040959
Researcher
Jeffrey Giguere
Keywords
Cancer/Genitourinary, Kidney, Stage IV
Summary

This randomized phase II clinical trial is studying giving sunitinib malate together with or without gemcitabine hydrochloride to see how well they work in treating patients with advanced kidney cancer that cannot be removed by surgery. Patients will be Randomized (put into a group by chance) into 2 groups. Group A will receive gemcitabine and Sunitinib. Group B will receive Sunitinib. Treatment cycles are 42 days long and will be repeated for total of 12 months. Follow-up will continue until patients have been on study for 3 years

Institution
Greenville
Recruitment Contact
Gina Norris
864-241-6251
gnorris@ghs.org

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

Date Added
December 17th, 2014
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 Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease Save

Date Added
December 9th, 2014
PRO Number
Pro00039734
Researcher
Roberto Pisoni
Keywords
Kidney
Summary

If you are an adult with Autosomal Dominant Polycystic Kidney Disease you may be eligible to take part in a clinical research study.
The purpose of this study is to find the potential benefits and safety of an investigational drug called tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease. If eligible, the study will involve 25 visits over a period of 15 months. Study drug, study visits, blood work and study procedures will be provided free of charge to qualified participants.

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

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 2nd, 2014
PRO Number
Pro00038759
Researcher
Katherine Twombley
Keywords
Adolescents, Children's Health, Disease Prevention, Kidney, Minorities, Pediatrics, Transplant, Vaccine
Summary

Adult and Pediatric patients with glomerular disease:
Patients of all ages are needed to participate in a research study to investigate glomerular disease and create a worldwide database to help in the research and future treatment of this disease. To join this study, you must have a type of glomerular disease, have had a first kidney biopsy within the last 5 years, not be on on dialysis, or have had a kidney transplant.

The study is projected to last 4 years, and all study procedures will be done at regular clinic visits (between 1 and 3 yearly). Study procedures include filling out questionnaires and a blood draw at each visit.

Compensation is available for study participation.

Institution
MUSC
Recruitment Contact
Anna Patton
843-792-9454
tecklenb@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 7th, 2014
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, 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
October 14th, 2014
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

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
September 2nd, 2014
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

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

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