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

The POSEIDON Kidney Disease Registry and Biobank Save

Date Added
May 17th, 2016
PRO Number
Pro00019764
Researcher
Michael Janech
Keywords
Kidney, Rare Diseases, Transplant, Urinary
Summary

Currently, kidney disease affects up to 20% of the US population and is a strong contributor to morbidity and mortality in these patients. Specific therapies and diagnostic tools for kidney disease have been very slow to develop because of the absence of high quality samples and data that can be used for research studies. The purpose of this study is to develop a registry and sample bank called Poseidon (Prevention, Optimizing Safety, Early Intervention and DetectiOn in Nephrology) biobank that can be used for future research. In this study, patients can consent to donating their residual kidney tissue if they undergo a kidney biopsy and blood or urine during routine clinical care procedures. This study will allow biomedical research the ability to obtain specimens from patients with relevant diseases and appropriate clinical data. This study will collect patient demographic, clinical and historical data for a registry and patient samples will be deposited in the Poseidon biobank. Patients do not have to be diagnosed with Kidney Disease to be included in this study.

Institution
MUSC
Recruitment Contact
Linda Walker
8437926109
walkerlp@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 300 subjects will be randomized in a 1:1 ratio using permuted block randomization stratified by surgeon and fistula location (radiocephalic or brachiocephalic). Approximately 150 subjects will receive an AV fistula plus the SeCI; the other 150 subjects will receive an AV fistula without the SeCI. 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

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
March 8th, 2016
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
January 27th, 2016
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

Lifestyle Intervention to Delay Kidney Disease Progression in African Americans with Type 2 Diabetes Save

Date Added
January 19th, 2016
PRO Number
Pro00051414
Researcher
Leonard Egede
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

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

Date Added
December 9th, 2015
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

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 1st, 2015
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 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
November 10th, 2015
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

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