A Multi-center, Open Label, Randomized Phase 2 Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma Save

Date Added
August 9th, 2016
PRO Number
Pro00055991
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

The purpose of this study is to evaluate the progression free survival (PFS) , based on investigator radiologic review, of AGS-16C3F compared to axitinib in adult subjects with metastatic renal cell carcinoma. The time frame for PFS is 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease Save

Date Added
June 14th, 2016
PRO Number
Pro00046888
Researcher
Roberto Pisoni
Keywords
Kidney
Summary

If you are an adult with Autosomal Dominant Polycystic Kidney Disease and have previously participated in a study with an investigational drug called tolvaptan, you may be eligible to take part in this clinical research study. The purpose of this study is to evaluate the long-term safety of an investigational drug called tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease. If eligible, you will be provided the investigational drug tolvaptan. Study drug, study visits, blood work and study procedures will be provided free of charge to qualified participants

Institution
MUSC
Recruitment Contact
Lori Spillers
843-792-8166
spillerl@musc.edu

A Phase 3, Randomized, Multicenter, Single-blind Controlled Study evaluating Arteriovenous fistula outcomes with and without a Perivascular Sirolimus-eluting collagen Implant in subjects on hemodialysis (The ACCESS Trial) Save

Date Added
April 15th, 2016
PRO Number
Pro00048577
Researcher
Thomas Powell
Keywords
Kidney, Surgery
Summary

Subjects of either gender, who are at least 18 years of age, undergoing hemodialysis, and require a new single-stage radiocephalic or brachiocephalic end-to-side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation (i.e., a patent fistula confirmed by the presence of a thrill and bruit with satisfactory hemostasis) will be eligible for enrollment. Approximately 230 subject are planning to be randomized in equal proportions to treatment and control to yield a minimum of 200 evaluable subjects. Evaluations to determine fistula suitability for cannulation will start no earlier than day 28 post index procedure and will continue to least weekly. All enrolled subjects will be followed for a period of one year from the time of their index procedure.

Institution
Palmetto
Recruitment Contact
Michelle Hardin
803-252-9907 ext 247
mhardin@columbianephrology.com

Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients Save

Date Added
March 15th, 2016
PRO Number
Pro00051804
Researcher
David Taber
Keywords
Cardiovascular, Kidney, Transplant
Summary

This study will provide evidence demonstrating the feasibility and the potential effectiveness of pharmacist-led technology interventions in an effort to improve medication adherence, medication safety and cardiovascular risk factor control within kidney transplant recipients.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Delay Early CKD with Lifestyle Interventions in African Americans with Diabetic Kidney Disease (DELAY DKD) Save

Date Added
January 19th, 2016
PRO Number
Pro00051414
Researcher
Mukoso Ozieh
Keywords
Kidney
Summary

This is an intervention study for African American adults with type 2 diabetes and early kidney disease. The aim of this study is to evaluate the impact of a lifestyle intervention on the progression of kidney disease.

Institution
MUSC
Recruitment Contact
Mukoso Ozieh
843-792-2456
osakwe@musc.edu

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 dialysis, or not 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 Tecklenburg
843-792-9454
tecklenb@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

A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad(®) vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) Save

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

Currently, vaccination against measles, mumps, rubella and varicella (MMRV) is recommended for healthy infants starting at 12 months of age. It is not recommended for immunosuppressed patients, such as transplant patients, who have an increased risk of serious complications from infections like varicella, mumps, measles and rubella.

For this research study, we plan to administer the first dose between 6 months and 24 months of age and the second dose at least 30 days but no more than 365 days after the first dose

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

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