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Clinical Trials

Clinical Trials

Wearable Artificial Kidney Trial (WAK)

  • Although dialysis is lifesaving, not much has changed with the therapy since it was first available to end-stage renal disease patients in 1960.
  • Most patients dialyze in a center three times a week. Many don’t feel well with that amount of dialysis and wish they weren’t restricted to an in-center dialysis schedule.
  • This trial tested an 11-pound wearable device that provided continual dialysis to patients with end-stage renal disease.
  • Seven patients tested the device and most wore it for a full 24 hours.
  • This trial provided proof of concept that a wearable device for dialysis could work for many kidney patients. It was well-received by patients, providing them more freedom and allowing them to be much less restrictive with their diet.
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)

  • Although depression is very common in dialysis patients, it is often undiagnosed and thus goes untreated.
  • Dialysis patients with depression are more likely to have complications like heart problems, and be hospitalized, and they are more likely to stop dialysis.
  • This trial compared two types of treatment—Cognitive Behavioral Therapy or treatment with an anti-depressant—for depression in patients with kidney failure.
  • Patients in the trial must be diagnosed with depression and treating their kidney failure with hemodialysis.
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)

  • People with kidney failure have an increased risk of heart failure.
  • Reducing blood pressure in people with kidney failure could help prevent heart problems.
  • 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 people with heart failure.
  • This trial is testing spironolactone on patients with kidney failure who are on hemodialysis.
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)

  • Although depression is very common in dialysis patients, it is often undiagnosed and thus goes untreated.
  • Dialysis patients with depression are more likely to have complications like heart problems, and be hospitalized, and they are more likely to stop dialysis.
  • This trial compared two types of treatment—Cognitive Behavioral Therapy or treatment with an anti-depressant—for depression in patients with kidney failure.
  • Patients in the trial must be diagnosed with depression and treating their kidney failure with hemodialysis.
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)

  • People with kidney failure have an increased risk of heart failure.
  • Reducing blood pressure in people with kidney failure could help prevent heart problems.
  • 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 people with heart failure.
  • This trial is testing spironolactone on patients with kidney failure who are on hemodialysis.
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)

  • People who treat their end stage renal disease with peritoneal dialysis, or PD, have similar survival rates as patients who use in-center hemodialysis.
  • People on PD report that they feel better than people on in-center hemodialysis and PD costs less to administer.
  • However, 20 percent of people on PD switch to hemodialysis every year.
  • Data suggests this could be because of a genetic problem with the peritoneal membrane.
  • This study aims to better understand the biology of peritoneal membrane function and how it is influenced by genes.
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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