PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
End Stage Renal DiseaseThe investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
The Effect of Combining Medium Cut Off Dialysis Membrane and Diet Modification on Reducing of Inflammation...
End Stage Renal DiseaseHaemodialysis3 moreThe investigators purpose is to research the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis membrane Theranova®) combined with diet modification to reduce the level of inflammation in chronic dialysis patients. The investigators hypothesize that the use of a medium-cut off dialysis membrane and dietary modification work synergistically and cause a significant and clinically meaningful reduction in inflammation levels compared to on-line hemodiafiltration with a high-flux dialysis membrane.
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)...
Kidney FailureChronic1 moreDuring end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.
Exercise in Patients With End Stage Kidney Disease
Renal FailureThis study will be conducted over a 3 year time period. This is a trial of an exercise intervention vs. standard of care in patients receiving chronic dialysis. The specific aims will be to determine feasibility of patient recruitment, adherence to the exercise program, and efficacy of the intervention on patient important outcomes. The exercise intervention will be delivered to randomized participants for 12 months, and consist of the prescribed use of Nordic Walking poles, online resources for exercise in the home, regular use of a pedometer to monitor progress, and regular verbal encouragement to exercise (monthly) by dialysis unit staff. Both groups will receive the same standard of care co-interventions including individualized dialysis prescriptions and health-care interactions according to practices at their centre.
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant...
End Stage Renal DiseaseKidney TransplantThis study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy. Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.
Randomized Controlled Trial on 3D Printed Assistive Device for Continuous Ambulatory Peritoneal...
Renal Failure ChronicTouch contamination during bag exchange in Continuous Ambulatory Peritoneal Dialysis (CAPD) is a common cause of CAPD-related peritonitis. An innovative 3D-printed assistive device "Helping Hands" was designed to minimize direct touch of tubing during CAPD bag exchange to allow a safer connection process for patients with Chronic Kidney Disease (CKD) to reduce the risk of CAPD-related peritonitis. Through this randomized control, the investigators aimed to evaluate the safety and efficacy of "Helping Hands" in CAPD bag exchange procedure for patients on CAPD therapy.
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal...
Coronary Artery DiseaseChronic Renal FailureThe current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion. Severely calcified coronary lesions are associated with worse outcomes. In this regard, chronic kidney disease is associated with severely calcified coronary arteries. Some evidence suggests that elective rotational atherectomy used by experienced operators can be safe and effective, minimizing time and complications for patients with heavily calcified lesions. However, there is no direct randomized comparison between rotational atherectomy and angioplasty alone in the setting of chronic renal failure and with intravascular ultrasound assessment for detecting severely calcified coronary arteries.
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone,...
Chronic Renal FailureMechanistic Effects of SGLT2 Inhibition and/ or MR Antagonism on Body Fluid and Electrolyte HomeostatisThe purpose of this study is to investigate the mechanistic effects of dapagliflozin 10 mg, alone or in combination with balcinrenone 150 mg, with balcinrenone 150 mg and placebo, on the way the body handles electrolytes and water content, as well as the effects these interventions may have on energy metabolism in participants with stage 3 chronic kidney disease. The study interventions will be administered orally, daily, in addition to current therapy, for a duration of 28 days. This will allow us to maximize our ability to detect a drug effect while minimizing the drop-out rate that accompanies longer studies. In order to understand the different mechanistic effects of these interventions on energy metabolism, the study will be conducted at two study sites. The study design and treatment allocation, treatment duration as well as sample analysis for evaluation of the primary endpoint will be identical for all participants, at both sites. Therefore, urine and plasma samples for analysis of water and electrolyte handling will be collected from all study participants at both sites. In addition to the primary endpoint, the main study site (Nuremberg) will conduct a metabolic study to investigate the early- and late-effects of the interventions, while the second site, Marseille, will conduct an imaging sub-study to assess changes at the tissue level before and after treatment.
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular...
Chronic Kidney DiseasesHeart Failure1 moreThe is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)
Study Investigating Whether Robot-assisted Surgery Can Reduce Surgical Complications Following Kidney...
End Stage Renal DiseaseKidney Transplant; ComplicationsThe purpose of this study is to explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation. Participants are adult recipients of kidney transplantation. Upon entry into the trial participants will be randomly assigned eiher open kidney transplantation or robot-assisted kidney transplantation. The participants in both groups will be treated in accordance with up-to-date guidelines and care. Our hypothesis is that robot-assisted surgery can reduce vascular complications by 15% and/or major surgical complicatons by 20% within 30 days of kidney transplantation compared to open surgery.