
Shared Decision Making and Renal Supportive Care
Chronic Kidney DiseaseThis year, 90,000 Americans with end-stage renal disease (ESRD) will die and questions will legitimately be raised as to whether terminal treatment and location of death adequately represented their preferences. These concerns are linked by a failure on the part of patients and staff to discuss prognosis and share in end-of-life (EOL) planning. The rate of hospice use among patients dying with ESRD is half that of the national average and one-quarter the rate for patients with terminal cancer. In other patient populations when meaningful EOL conversation occurs this is associated with increased hospice referral and improved quality of the dying. Patients receiving hemodialysis (HD) often desire but rarely communicate with staff about prognoses, know little about availability of community hospice resources, or how to complete advance directives. Nephrologists are not trained to have these conversations, and although accustomed to relying on interdisciplinary teams, they are unaccustomed to collaborating with community hospices. Our preliminary research began by using focus groups, created and validated the first clinically useful HD prognostic tool, and developed a prototype for Shared Decision Making and Renal Supportive Care (SDM-RSC). This is a novel multimodal intervention that familiarizes patients, families, and dialysis staff with community hospice resources, emphasizes dialysis social work support, conveys information about terminal care issues, and encourages advance care planning. The proposed study tests the central hypothesis that EOL care can be improved by relying on patients and stakeholders to enhance SDM-RSC for HD patients who are most likely to die. It will test whether an intervention that targets communication deficiencies can alter EOL outcomes and achieve the goal of matching patient preferences with terminal treatments.

Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease
Chronic Renal DiseaseRenal AnemiaDS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to produce transient dose / exposure dependent increases in erythropoietin levels in subjects with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to dose will be randomised. On completion of this part of the study an optional fourth dose may be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects (n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from Part A.

The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer...
Diabetic Kidney DiseaseObjective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics. Indication Diabetic kidney disease Efficacy Primary AUClast, AUCinf, AUClast/D, AUCinf/D Cmax, Cmax/D Secondary Tmax, t1/2, CL/F, Vz/F Safety Adverse Event Monitoring V/S, EKG, Laboratory Test, P/E

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal...
Relapsed Multiple MyelomaEnd-stage Renal DiseaseThe purpose of this study is to see how the body and the cancer react to carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal...
End Stage Renal DiseaseThis study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.

Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis...
Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis TherapyPharmacodynamics of ASP79911 moreThis study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.

Effect of Probiotic Consumption on Chronic Kidney Disease
Chronic Kidney DiseaseRecent studies have demonstrated that the balance of intestinal microbiota is affected in chronic kidney disease (CKD), leading to a condition known as intestinal dysbiosis. These changes were associated with metabolic complications, accumulation of uremic toxins, inflammation, progression of CKD and cardiovascular risk. Measures with the aim of restore the balance of intestinal flora are suggested, such as the intake of probiotics composed of beneficial bacteria, but few studies have discussed the effect of these supplements in CKD. The present study aims to evaluate the effect of consumption of probiotics in factors associates with progression of CKD and cardiovascular risk. To such will be conducted a double-blind, placebo-controlled, and randomized clinical trial with 30 patients with CKD in stages 3-5, treated in ambulatories of Nephrology of the Hospital de Clínicas de Porto Alegre, independently of etiology and with steady renal function. Patients will be excluded whether in substitutive renal therapy, kidney transplant, on antimicrobial therapy or immunosuppressive agents in the last three months or with acute clinical events. The assessment will include clinical and nutritional parameters, estimated glomerular filtration rate, proteinuria, serum lipids, inflammatory factors, and bowel habits. The study protocol includes the recruitment of patients who will undergo to 4-week washout period. After patients will be randomized and provided with probiotic therapy (intervention group) or placebo (maltodextrin; control group) for 24 weeks. All patients will be instructed to consume 2 sachets/day of probiotic or placebo and receive nutritional advice. All data will be analysed by the principal investigator with the support of a trained statistician and the chief investigator. The statistical programme SPSS will be used.

Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1...
Polycystic Kidney DiseasesThe purpose of this study is to find a protein (ex. Polycystin 1 or mucin and cadherin like protein) in the urine that is changed after treatment of hydralazine.

Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
Safety IssuesChronic Kidney DiseasesThe benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead to volume depletion (dehydration), and increase the risk of kidney function loss and acute kidney injury (AKI). It is not known how frequent significant sick-days occur in CKD patients, or whether a patient self-managed Sick-Day Protocol (SDP) that temporarily holds RAS blocker, diuretics, or other high risk medication in an effort to preserve renal function, or prevent AKI. The purpose of the study is to asses if a SDP, monitored remotely with a weekly automated phone survey , can improve outcomes in CKD (such as slow renal function loss and AKI episodes) and reduce preventable service utilization versus usual care.

Sit Less, Interact, Move More (SLIMM) Intervention for Sedentary Behavior in Chronic Kidney Disease...
Chronic Kidney DiseaseSedentary behavior is engaging in activities in the seated or lying position that barely raise the energy expenditure level and has emerged as an important risk factor for obesity, diabetes, cardiovascular disease and mortality. The primary hypothesis is that the Sit Less, Interact, Move More (SLIMM) intervention in Chronic Kidney Disease (CKD) will be effective in decreasing sedentary duration by increasing casual walking duration and thereby, increase physical activity energy expenditure.