Systolic Blood Pressure Intervention Trial (SPRINT) + save

Date Added
June 18th, 2013
PRO Number
Pro00012179
Researcher
Ruth Campbell
Keywords
Hypertension/ High Blood Pressure, Kidney
Summary

The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.

Institution
MUSC
Recruitment Contact
Caroline Counts
843.792.8980
counts@musc.edu

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

Date Added
June 4th, 2013
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

Pilot study to assess relative merits of Hexabrix versus Visipaque for risk of acute kidney injury post cardiac catheterization and intervention. + save

Date Added
May 28th, 2013
PRO Number
Pro00020077
Researcher
Richard Katzberg
Keywords
Cardiovascular, Kidney
Summary

Patients over 18 years of age who are scheduled for a cardiac catheterization procedure at the Medical University of South Carolina will have the opportunity to participate in a study to see if signs of Acute Kidney Injury could be detected earlier (through urine biomarkers) than it would be normally (through changes in kidney blood tests). Participants will be randomized to one of two iodinated contrasts (Hexabrix or Visipaque) and will be asked to undergo a CT scan of the kidneys 24 hours after the cardiac catheterization procedure.

Institution
MUSC
Recruitment Contact
Aleksander Krazinski
(843)876-7148
krazinsk@musc.edu

An Open-Label, Multicenter Phase Ib/2 Stndy of E7080 Alone, and in Combination with Everolimus in Subjects with Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment + save

Date Added
May 28th, 2013
PRO Number
Pro00013342
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Kidney
Summary

This study is for subjects that have have been diagnosed as having advanced renal cell carcinoma that has been treated previously, but has not responded or got worse despite treatment. E7080 is an investigational drug that is in development for the treatment of cancer, including renal cell carcinoma. E7080 is thought to work by stopping the formation of new blood vessels that help cancer cells grow and spread. Everolimus is also used in this study and is a drug approved by the FDA and other Health Authorities for the treatment of advanced renal cell carcinoma. Subjects will either receive E7080, Everolimus or both drugs together. Also being studied is how your genetic make up affects how your body absorbs, distributes, breaks down and excretes the study drugs. There will be a screening visit to determine subjects eligibility and a baseline visit that will determine is subjects are still eligible to participate in this study. If subjects are eligible and choose to participate, then subjects will be assigned to one of three study groups. Each treatment cycle is 28 days long. Subjects are expected to be on this study for approximately 24 months or 2 years.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Bleeding disorders in autosomal dominant polycystic kidney disease (ADPKD) + save

Date Added
May 17th, 2013
PRO Number
Pro00010835
Researcher
Ruth Campbell
Keywords
Kidney
Summary

The puropose of this study is to determine if autosomal dominant kidney disease (ADPKD) in humans is associated with disordered hemostasis. If persons with ADPKD do indeed have a bleeding disorder there are implications for their daily lives. This discovery would need to be investigated further and subsequently shared in a scholarly manner.

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

Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors + save

Date Added
April 9th, 2013
PRO Number
Pro00016841
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Kidney
Summary

Subjects are being asked to take part because they have clear cell renal cancer that has spread to other organs in their body. Renal cell carcinoma is the cancer that develops in the kidneys.
The purpose of this study is to test a new cancer treatment drug called BNC105P in combination with everolimus to see what effects (good and bad) it has on subjcets and their cancer. BNC105P is a drug that causes changes in the lining of the blood vessels nourishing the tumor cells more than the lining of the blood vessels nourishing the normal cells. These changes in the lining of the blood vessels reduces blood flow to the tumor causing reduced blood supply/nourishment to the tumor resulting in death of the tumor cells and reduction of the tumor size.
This study will be done in 2 parts; Phase I and Phase II.
The purpose of the Phase I part of the study is to:
• test the safety of BNC105P (a new type of drug used to treat cancer) when given together with Everolimus
• find the highest dose of BNC105P that can be given together with Everolimus without causing severe side effects
• see what effects (good and bad) BNC105P has on you and your cancer

The purpose of the Phase II part of the study is to:
• Evaluate if adding BNC105P to the Everolimus is better than Everolimus treatment when given alone and see what effect (good or bad) BNC105P will have when given following Everolimus treatment.

Subjects will have screening procedures to determine if he or she is eligible to participate in this study. If he or she is eligible and agrees to participate, subjects will either participate in Phase I or Phase II. Subjects in Phase I will receive EVEROLIMUS at 10 mg by mouth daily and BNC105P by IV.

If subjects are in the Phase II portion of the study, they will be randomized in to either Group A or Group B. Group A subjects will also receive EVEROLIMUS at 10 mg by the mouth daily and BNC105P by IV. Subjects in Group B will receieve EVEROLIMUS at 10 mg by mouth daily only.

Subjects will be followed by study team members for the rest of their lives to look at the long term effects of the study treatment.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@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 25th, 2013
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
January 2nd, 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

Urinary markers for determination of intravascular volume depletion + save

Date Added
November 29th, 2012
PRO Number
Pro00020365
Researcher
Line Malha
Keywords
Kidney, Urinary
Summary

The purpose of this study is to find out if the presence or absence of certain molecules in a patient's urine can help determine how much fluid they have in their blood vessels (intravascular volume status). Urine samples will be collected after consent in approximately 150 volunteers in order to check for presence or absence of urinary markers. Information will be collected from medical records in order to have information about the patient's intravascular volume status. Analysis will be done to check if presence or abscence of urine markers can be associated with low intra-vascular volume.

Institution
MUSC
Recruitment Contact
Line Malha
8437922123
malha@musc.edu

Incidence, risk factors, and outcomes associated with adverse drug reactions and medication errors within kidney transplantation + save

Date Added
November 16th, 2012
PRO Number
Pro00020011
Researcher
Justin Spivey
Keywords
Kidney, Transplant
Summary

This study is a retrospective chart review that will be conducted by the primary investigator aimed at determining the association between adverse drug reactions and medication errors with negative outcomes. These negative outcomes are defined as the occurrence of acute or chronic rejection. Data will be collected by chart review of patients meeting the inclusion and exclusion criteria between March 2009 and July 2011. Charts will be reviewed for information as outlined by the data monitoring form. Statistical analysis will be performed according to the appropriate statistical test. Estimated timeline following IRB approval is data collection from September through November and final manuscript draft and submission May.

Institution
MUSC
Recruitment Contact
David Taber
792-8532
taberd@musc.edu