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Clinical Trials

Clinical Trials

Wearable Artificial Kidney Trial (WAK)

Participants underwent 24 hours in-hospital treatment with the Wearable Artificial Kidney (WAK). Up to 10 subjects with ESRD will complete the protocol in its entirety. The objective of this protocol is to provide additional preliminary data supporting the hypothesis that the WAK safely and effectively delivers dialysis therapy that is at least equal to the current standard of care for treatment of ESRD using conventional machines for thrice weekly hemodialysis treatments. These objectives would be accomplished by absence of adverse events during treatment with the WAK, along with effective removal of fluid and solutes at least equal to those delivered with conventional currently used dialysis machines. The WAK will be the only investigational device used in this study. The reason for this trial is to advance the eventual approval of this device to be legally commercialized as it potentially may respond to the unmet public health needs to improve outcomes and reduce costs in the treatment of ESRD patients. ClinicalTrials.gov NCT02280005

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Clinical Trials

Treatment Options for Depression in Patients Undergoing Hemodialysis (ASCEND Trial)

The purpose of the ASCEND study is to compare two types of treatment for depression in participants who have end-stage renal disease and who have been diagnosed with depression.  The two types of treatment involved in the study are Cognitive Behavioral Therapy (CBT) or treatment with an anti-depressant.  The researchers hope to enroll 180 participants who are undergoing hemodialysis in three study locations (Seattle, Washington, Dallas, Texas, and Albuquerque, New Mexico).  A third group of 90 participants from the three study locations have chosen not to receive any treatment for depression will be asked to take part in a phone survey for up to three months.  The entire study will take approximately 2 years to complete. ClinicalTrials.gov NCT02358343

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Clinical Trials

Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End Stage Renal Disease (Spin-D)

The purpose of the Spin-D trial is to test the safety, tolerability, and efficacy of spironolactone for patients with kidney failure on chronic hemodialysis.  Spironolactone is a drug that has been used for many years to reduce blood pressure. Recently the drug has been found to increase the life expectancy of patients with heart failure.  People with kidney failure have an increased risk of heart failure due to thickening of the heart wall and an increased risk of abnormal heart rhythms.  Although spironolactone has been approved for treating heart failure, it is not known whether this benefit occurs in patients with kidney failure. ClinicalTrials.gov NCT02285920

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Grants

Grants

Treatment Options for Depression in Patients Undergoing Hemodialysis (ASCEND)

The purpose of the ASCEND study is to compare two types of treatment for depression in participants who have end-stage renal disease and who have been diagnosed with depression.  The two types of treatment involved in the study are Cognitive Behavioral Therapy (CBT) or treatment with an anti-depressant.  The researchers hope to enroll 180 participants who are undergoing hemodialysis in three study locations (Seattle, Washington, Dallas, Texas, and Albuquerque, New Mexico).  A third group of 90 participants from the three study locations have chosen not to receive any treatment for depression will be asked to take part in a phone survey for up to three months.  The entire study will take approximately 2 years to complete.

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Grants

Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End Stage Renal Disease (Spin-D)

The purpose of the Spin-D trial is to test the safety, tolerability, and efficacy of spironolactone for patients with kidney failure on chronic hemodialysis.  Spironolactone is a drug that has been used for many years to reduce blood pressure. Recently the drug has been found to increase the life expectancy of patients with heart failure.  People with kidney failure have an increased risk of heart failure due to thickening of the heart wall and an increased risk of abnormal heart rhythms.  Although spironolactone has been approved for treating heart failure, it is not known whether this benefit occurs in patients with kidney failure.

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Grants

Biological Determinants of Peritoneal Dialysis Outcomes (Bio-PD)

Patients with end-stage renal disease (ESRD) treated with peritoneal dialysis (PD) have similar long-term survival as of patients treated with in-center hemodialysis but have better patient-reported outcomes and the therapy can be delivered at a lower societal cost. The use of PD for the treatment of ESRD is increasing in the United States but annually, 20% of patients still transfer to hemodialysis from PD-related complications (technique failure). Successful management of ESRD with PD requires the movement of adequate amounts of solutes and fluid across the peritoneal membrane. The data to date suggest that the variability in peritoneal membrane function and injury may, in part, be genetically determined. However, candidate gene association studies have produced inconsistent results, have examined a limited number of mechanistic pathways, and a small proportion of the variation in a handful of genes. Hence, there is a need to comprehensively determine whether the variability in peritoneal membrane function is determined genetically. Identification of common genetic variants associated with peritoneal membrane function and injury has the potential to lead to the development of biomarkers for early detection of peritoneal membrane injury, and/or identify therapeutic targets to preserve peritoneal membrane function in the future. Given the importance of peritoneal membrane function to successful PD, there is a critical need to better understand the biology of peritoneal membrane function and how it is influenced by genetic variation. Thus, the central hypothesis of this proposal is that common genetic variants explain the inter-individual variability in peritoneal membrane function in patients undergoing PD.

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