A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event driven Phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease Save

Date Added
October 10th, 2017
PRO Number
Pro00069773
Researcher
Roberto Pisoni
Keywords
Diabetes, Kidney
Summary

If you are an adult with type 2 diabetes mellitus and diabetic kidney disease, you may be eligible to take part in a clinical research study.
The purpose of this study is to find out if an investigational drug called finerenone slows the progression of diabetic kidney disease. Qualified participants will be randomly assigned to take either finerenone 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
Lori Spillers
843-792-8166
spillerl@musc.edu

A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study to investigate the efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care. Save

Date Added
October 10th, 2017
PRO Number
Pro00070030
Researcher
Roberto Pisoni
Keywords
Diabetes, Kidney
Summary

If you are an adult with type 2 diabetes mellitus and diabetic kidney disease, you may be eligible to take part in a clinical research study.
The purpose of this study is to find out if an investigational drug called finerenone slows the progression of diabetic kidney disease. Qualified participants will be randomly assigned to take either finerenone 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
Lori Spillers
843-792-8166
spillerl@musc.edu

More than Facebook Effect: Increasing opportunities for living kidney donation Save

Date Added
September 5th, 2017
PRO Number
Pro00065466
Researcher
Wendy Balliet
Keywords
Kidney, Transplant
Summary

Kidney transplant, especially from a living donor, affords End Stage Renal Disease (ESRD) patients the opportunity for increased survival and improved quality of life. Potential recipients are not likely to identify living donors as a believed consequence of lack of awareness and limited knowledge regarding living kidney donation. We propose to utilize a social media coach to help ESRD patients to utilize Facebook to tell their ESRD story, to post accurate information and links to data on ESRD, renal transplantation and living donation with the goal of increasing interest in social media 'friends' to become a living donor.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan
Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

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

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