Pathway Exploration and Analysis in Renal Lupus Save

Date Added
July 18th, 2017
PRO Number
Pro00067258
Researcher
Diane Kamen
Keywords
Autoimmune disease, Kidney, Lupus
Summary

The purpose of the study is to characterize the inflammatory response in lupus nephritis kidneys in order to identify the cellular and molecular pathways of injury. It will involve patients who are already scheduled to have a kidney biopsy to clarify the diagnosis of lupus nephritis and/or to guide therapy. During the biopsy, doctors will take an extra "core" of kidney tissue for research purposes in addition to the one used for clinical reasons. If you enroll in the trial, you will have 7 visits, including your kidney biopsy. The first two visits occur within 2 weeks, then follow up visits after 3, 6, 12, 18 and 24 months.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Confirm Efficacy and safety of Terlipressin in Subjects with Hepatorenal Syndrome Type 1 (The CONFIRM Study) Save

Date Added
May 23rd, 2017
PRO Number
Pro00066692
Researcher
Don Rockey
Keywords
Kidney, Liver
Summary

The purpose of this study is to confirm the efficacy and safety of terlipressin in the treatment of adult subjects admitted to the hospital with hepatorenal syndrome (HRS) Type 1. Hepatorenal syndrome Type 1 is a severe, but potentially reversible, form of renal failure that afflicts patients with severe chronic liver disease associated with cirrhosis. This will be a randomized, placebo-controlled, and double-blinded multi-center study. Patients will be randomly be placed in either a terlipressin-treatment group or a placebo group. Neither you nor the study team will know which group you have been placed in. The study drug will be given as an IV injection every 6 hours while the patient is an inpatient at the hospital every 6 hours. This is a phase 3 study, with prior studies already showing promising results.

Institution
MUSC
Recruitment Contact
Mona Haj
8438760581
hajm@musc.edu

Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System Save

Date Added
January 10th, 2017
PRO Number
Pro00059528
Researcher
Katherine Twombley
Keywords
Blood Disorders, Kidney, Pediatrics
Summary

A device called the ?Liposorber LA-15 System? has been approved by the United States Food and Drug Administration for treating kids with focal segmental
glomerulosclerosis (FSGS). The ?Liposorber LA-15 System? can only be used if other treatment options, like drugs, don?t work or can?t be used, but the kidneys are still working okay. It can also be used if the subject has had a kidney transplant and the FSGS comes back after the transplant. Although the Liposorber System can be used for FSGS, we are not sure how well the Liposorber System works. So, we are doing this study to find out how well the treatment works.

In this research study, there will be up to 5 children who have FSGS enrolled at MUSC. Subjects will come back for up to 12 treatments over 9 weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

A phase 3 randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa. Save

Date Added
December 13th, 2016
PRO Number
Pro00058563
Researcher
Ruth Campbell
Keywords
Kidney
Summary

The ASCEND-ND clinical research study is looking for
adults who have anemia caused by Chronic Kidney Disease. The study
doctors are testing an investigational medication to
see if it may safely boost production of EPO, thereby
increasing red blood cell production. (?Investigational?
means this medication isn?t yet approved for use by
the public.) This medication is a tablet that?s taken daily by mouth. Those who volunteer and qualify for this research study will receive all study-related medication and care at no cost.

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

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
Michael Lilly
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 130 - 230 subjects are planned to be randomized in equal proportions to treatment and control to yield a minimum of 100 - 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

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
Theodore Gourdin
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

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