Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease...
Chronic Kidney DiseasesDialysis-dependent Kidney Failure1 moreThe TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited. The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).
SVF (Adipose Tissue Derived MSC) Based Therapy for CKD.
Chronic Kidney DiseasesTo assess the safety of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD). To assess the efficacy of stromal vascular fraction (Autologous Non-Expanded ADSC) injection in patients with Chronic Kidney Disease (CKD).
Sit Less, Interact and Move More (SLIMM) 2 Study
Chronic Kidney DiseasesObesityProlonged sitting (sedentary behavior) is a risk factor for decreased kidney function, obesity, diabetes and mortality. Prolonged sitting is associated with decreased kidney function and increased risk of diabetes, heart disease and death. In a previous pilot study funded by NIH, it was shown that a Sit Less, Interact and Move More (SLIMM) intervention targeting sedentary behavior in people with kidney disease was able to decrease prolonged sitting but that effect was not sustained. Therefore, the researchers are currently conducting a follow-up study named Sit Less, Interact and Move More (SLIMM) 2. This NIH funded study is conducted at the University of Utah and Stanford University. The purpose of this study is to see if guided resistance training (to improve muscle strength) and semaglutide (FDA approved diabetes and weight loss medication that might also improve physical function) can boost adherence to the SLIMM Intervention and reduce sedentary behavior.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion...
Chronic Kidney DiseasesThis trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Chronic Kidney Disease.
The Arteriovenous Vascular (AV) ACCESS Trial
End-Stage Kidney DiseaseHemodialysis ComplicationThis study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions
Multimodal Prehabilitation in Frail and Non-frail Patients Waiting for a Kidney Transplantation...
Chronic Kidney DiseasesFrailty is very frequent among patients waiting for a kidney transplantation (KT). Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Frailty in patients with chronic kidney disease (CKD) displays a constellation of features that characterize a special population. Intervention is essential to improve quality of life for frail CKD patients, regardless of their age. A pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after KT, and improve main outcomes in frail CKD patients. The main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail KT candidates on clinical and functional outcomes after KT.
Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of iMN
Idiopathic Membranous NephropathyThe primary objective of this study is to determine whether or not cyclosporine (CsA) combined with RTX is more effective than RTX alone in the treatment of idiopathic membranous nephropathy (iMN).
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney CalculiKidney Diseases4 moreStone disease is a common condition, affecting approximately 9% of Americans in 2007. It causes great morbidity and is also a costly condition, estimated to cost the US healthcare system approximately 3.79 billion dollars in 2007. Ureteroscopy (URS) is the most commonly performed surgical treatment for upper tract stone disease. Ureteral stenting is a common practice after ureteroscopy and placed in ~75% of cases to prevent ureteral edema and renal obstruction. Unfortunately, ureteral stenting can be very painful and has been shown to increase the rate of emergency room visits. Many strategies have been attempted to decrease pain with ureteral stenting including modification of stent material and designs, but efforts so far have been unsuccessful in decreasing stent-related morbidity. Stent-related morbidity is hypothesized to be secondary to irritation of ureteral/bladder mucosa and muscle. Analgesics such as alpha blockers and NSAIDs have been shown to reduce stent morbidity. Anticholinergic drugs are also utilized as they decrease bladder spasms and, therefore, are hypothesized to reduce stent irritation. However, the evidence for anticholinergics has been conflicting. Anticholinergics also have a serious side effect profile including dry mouth, dry eyes, constipation, urinary retention, blurred vision, and even dementia. Some authors even hypothesize that these side effects may offset any purported benefits the anticholinergics provide for stent-morbidity. Methocarbamol is anti-spasmodic muscle relaxant that is believed to work by acting on central neurons and possibly by blocking sodium channels. Given that anticholinergics have many side effects and questionable efficacy, the investigators hypothesize that methocarbamol may achieve superior analgesia for stent morbidity and stent-related bladder spasms. Oxybutynin is used for the treatment of overactive bladder. The rationale is that the oxybutynin relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination caused by the urinary stent irritation. Since anticholinergics have multiple side effects, finding an equally efficacious alternative with less side effects is highly desirable. This study will evaluate the clinical and demographic factors of patients undergoing ureteroscopy and treated postoperatively with methocarbamol vs. oxybutynin for stent-related morbidity. Additionally, the study will aim to understand the postoperative outcomes and complication rates of patients discharged with methocarbamol vs. oxybutynin after ureteroscopy with a ureteral stent in place.
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney DiseaseEnd-Stage2 moreA prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD
Chronic Kidney DiseasesThis Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.