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Kidney Failure, Chronic clinical trials

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NCT ID: NCT05614115 Recruiting - Hemodialysis Clinical Trials

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

NCT ID: NCT05606484 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Effect of Exercise With Virtual Reality in Hemodialysis Patients

Start date: June 9, 2023
Phase: N/A
Study type: Interventional

Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study. Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.

NCT ID: NCT05596760 Recruiting - Quality of Life Clinical Trials

Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers

PICSI-M
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.

NCT ID: NCT05407272 Completed - Stroke Clinical Trials

Explore the Sharing Model Intervene to Improve the Knowledge, Attitudes, Service Intentions and Service Start-up Effects of the Eight Major Non-cancer Disease End-stage Caregivers on Well-being and Palliative Care

Start date: September 14, 2021
Phase: N/A
Study type: Interventional

Since September 1st, 2009, Taiwan has begun to pay attention to the care of patients with organ failure, dementia and the elderly, and brought eight of non-cancer terminal patients into health insurance subsidies to implement the goal of universal palliative care and local aging. Taiwan has entered the aged society since March 2018, become the heavy burden of expenditure in Taiwan because of the health care needs and costs associated with the rapid aging of the population. With advanced medical technology, when facing inevitable death situation, should not use too much medical treatment on terminally ill patients. The waste of medical resources and bring both patients and family members so much pain. In Taiwan, people have misconception about tranquil palliative care. The low rate of home palliative care for non-terminal cancer patients. The purpose of this study is investigating the eight non-cancer terminal caregivers' knowledge, attitudes and service intentions of palliative care, and getting the result by research intervention. In this study, a randomized experimental research design was applied by two-group pre-and post-test. The targets are the eight non-cancer terminal caregivers in a home care institution of a regional teaching hospital located in Yilan. Targets' ID end with odd numbers are in experimental group received shared mode intervention, and even numbers are in control group received home routine care. The experimental group was implementing measures of weekly shared mode intervention in 20 to 60 minutes for six weeks; the control group started to implement measures of home care medical instructions booklet in the third week. The content of the outcome measurement questionnaire includes: basic information of the eight non-cancer terminal caregivers, the palliative care knowledge scale, the palliative care attitude scale, and palliative care service initiation intention scale. Data were analyzed by statistical methods such as descriptive analysis, independent sample t-test, paired-samples t-test, Pearson correlation analysis and one-way ANOVA.

NCT ID: NCT05399420 Not yet recruiting - Clinical trials for Kidney Failure, Acute

Study of Kidney Circulating Cell-free DNA in Patients With Acute Kidney Failure

ADNIRA
Start date: September 10, 2022
Phase:
Study type: Observational

The amount of total circulating DNA has been shown to increase in patients with acute renal failure. Nevertheless, it is currently not currently possible to prove the renal origin of this circulating DNA. Recently, in healthy subjects, teams have shown that it is possible to identify its tissue origin of circulating DNA. CGenetix is a MedTech company which develops on an identical principle an in vitro diagnostic test capable of identifying and quantifying renal degradation during an acute trauma. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating DNA of renal origin released into the general circulation in patients with acute organic and functional renal failure. Patients with functional or organic kidney deficiency will be included and the kidney biomarkers develop by CGenetix will be compared between these 2 groups of patients.

NCT ID: NCT05384899 Active, not recruiting - Covid19 Clinical Trials

Kidney Precision Medicine Project (KPMP) - COVID-19 Protocol

Start date: June 15, 2021
Phase:
Study type: Observational

Since its inception, KPMP has developed sophisticated protocols for collection and analysis of human kidney tissue, and for collection of biofluids. Members of the consortium have wide-ranging expertise in conducting clinical studies, processing kidney tissue, advanced structural and molecular analysis and complex bioinformatics analysis, which will be used to leverage effectively as a group to better understand kidney disease. This joint protocol aims to synergize the COVID-19 study efforts of KPMP academic research centers, to collectively study COVID-19, including its renal presentation using kidney tissue and/or biofluids from patients suffering from COVID-19. This will increase the breadth and depth of data available to the public to expedite discoveries, identify therapeutics, and improve outcomes for patients with COVID-19. It will additionally bring the expertise of KPMP investigators to bear against this pandemic.

NCT ID: NCT05381961 Active, not recruiting - Hemodialysis Clinical Trials

Observational Study of BIS in Hemodialysis Patients

Start date: April 4, 2022
Phase:
Study type: Observational

This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.

NCT ID: NCT05374291 Enrolling by invitation - Heart Failure Clinical Trials

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD. There are two cardiac sub-studies: the cardiac MRI substudy and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP HF in PD) study. In STOP HF in PD the effect of dapagliflozin on cardiac function will be assessed in a subset of 100 patients treated with peritoneal dialysis.

NCT ID: NCT05340426 Withdrawn - Clinical trials for Kidney Failure, Chronic

Porcine Kidney Xenotransplantation in Patients With End-Stage Kidney Disease

Start date: January 31, 2024
Phase: Phase 1
Study type: Interventional

The mismatch between organ supply and demand results in the deaths of thousands of Americans each year. Our research group aims to solve this unmitigated health care crisis by translating advances in xenotransplantation to humans and expanding organ supply in a sustainable fashion using genetically modified pigs as a source of organs. We propose here a phase I clinical trial of porcine kidney xenotransplantation into 20 people with end-stage kidney disease. Source donor animals are pigs with 10 gene edits (10-GE) which attenuate immunologic harm to the kidney xenograft. 10-GE pigs are housed in a designated pathogen-free facility within 30 minutes of the transplantation center. Xenotransplantation procedures follow conventional practices currently employed in allotransplantation and comply with multiple regulatory standards to ensure ethical treatment of research subjects and source animals. Recruitment and xenotransplantation will occur over 5 years with study follow-up extending 1 year after xenotransplantation. Primary outcome variables surround patient safety, such as patient survival and the rate of zoonotic disease transmission. Secondary outcome variables include commonly used metrics of graft survival and function.

NCT ID: NCT05335005 Completed - Clinical trials for Kidney Failure, Chronic

MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)

Start date: May 30, 2022
Phase: Phase 1
Study type: Interventional

MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 receptor inhibitor, clopidogrel, in ESRD patients.