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Kidney Failure, Chronic clinical trials

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NCT ID: NCT06351813 Not yet recruiting - Critical Illness Clinical Trials

Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

Start date: April 1, 2024
Phase:
Study type: Observational

The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.

NCT ID: NCT06343727 Not yet recruiting - Frailty Clinical Trials

A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: - To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. - To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. - To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.

NCT ID: NCT06243731 Not yet recruiting - Kidney Failure Clinical Trials

A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation

Start date: May 30, 2025
Phase:
Study type: Observational

The main aim of this study is to assess the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with kidneys that are no longer functioning on their own (also called end-stage renal disease or ESRD) or have severe chronic kidney disease requiring artificial filtering of the kidney (dialysis) or the blood (hemodialysis). In this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.

NCT ID: NCT06217302 Not yet recruiting - Heart Failure Clinical Trials

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

SUGARNSALT
Start date: May 2024
Phase: Phase 3
Study type: Interventional

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

NCT ID: NCT06082063 Not yet recruiting - Heart Failure Clinical Trials

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Steno1
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.

NCT ID: NCT06060951 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

RAPPER
Start date: October 1, 2023
Phase:
Study type: Observational

This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.

NCT ID: NCT06056102 Not yet recruiting - Kidney Failure Clinical Trials

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

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

This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.

NCT ID: NCT05968391 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

RENO-TEP
Start date: September 2023
Phase:
Study type: Observational

The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

NCT ID: NCT05719376 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes

Start date: February 2023
Phase: Phase 4
Study type: Interventional

RBC transfusion (RBCT) after kidney transplantation(KT) is about 50%. Anemia is common after kidney transplant surgery due to intraoperative blood loss, delayed graft function, and side effects of immunosuppressive drugs. However, due to exposure to non-self human leukocyte antigens (HLA) from blood transfusion, there is a risk of sensitization to HLA through the production of anti-HLA antibodies. In renal transplant patients, exposure to non-self HLA antigens due to RBCT can lead to the generation of donor-specific antibodies (DSA) against renal allograft donors. Patients who have undergone KT are frequently exposed to RBCT, and immunologic damage resulting from this can be an important cause of loss of graft kidney function. Therefore, there should be a more careful review of the risk associated with RBCT on KT recipients. Of the 16,191 Koreans who underwent KT between 2008 and 2017, 59.7% received transplant-related blood transfusions. As a result of analyzing 13,871 Koreans who underwent KT between 2007 and 2015, the overall graft failure rate was 15.5%, and the hazard ratio of survival rate according to RBCT before and after KT increased as the amount of transfusion increased. RBCT before and after KT was independently associated with graft failure and death. Therefore, research on treatment methods that can effectively reduce blood transfusion in transplant patients is absolutely necessary. About 30-60% of patients undergoing major surgery show preoperative anemia, which causes blood transfusions, complications during hospitalization, prolonged hospitalization, and delayed recovery. The most common cause of anemia is iron deficiency. In particular, an increase in hepcidin, a major regulator of iron metabolism, reduces intestinal iron absorption and promotes iron sequestering by macrophages, resulting in a state of functional iron deficiency. Therefore, oral iron intake as a treatment for anemia in surgical patients is not effective. Although the safety and clinical superiority of high-dose intravenous iron therapy have been demonstrated in patients with chronic renal failure, the effect of this drug on blood transfusion of pre- and post-kidney transplant surgery has not been studied. Therefore, this study aims to verify the effectiveness and stability of the combined administration of intravenous(IV) iron and erythropoiesis-stimulating agents(ESA) before and after KT for patients who perform KT for end-stage kidney disease(ESKD). The investigators will analyze hemoglobin, transferrin saturation, ferritin changes, and transfusion requirements according to the combined administration of IV iron and ESA before and after surgery of kidney transplant patients. Also, the investigators evaluate whether a treatment combining IV iron and ESA will be possible as an alternative blood transfusion treatment and its effect on the clinical prognosis of KT recipients. In particular, the effect on the function of the graft kidney, immunological outcomes-DSA, antibody-mediated rejection, and survival rate will be analyzed. Also, the investigators will analyze the change in expression of hepcidin and oxidative stress markers before and after kidney transplantation and the mechanism of expression according to the combined administration of IV iron and ESA. This study is a multicenter(including 3 centers), open-label, prospective, and randomized clinical trial. 302 patients undergoing living-donor KT for ESKD are randomly assigned in a 1:1 ratio to an experimental group actively using IV iron and ESA, and a control group receiving conventional anemia treatment for 42 months from the time of IRB approval. Participants selected for the experimental group will be given a total of 1000 mg of IV Monofer(iron isomaltoside); each 200 mg dose on 28, 21, and 7 days before kidney transplantation, on the day of surgery, and 7 days after surgery. In the case of ESA, it is freely used according to the criteria up to 7 days before transplantation and subcutaneously injected with 120 mcg of Mircera(methoxy polyethylene glycol-epoetin beta) between 7 days before surgery and a day before surgery. In the control group, IV Monofer is administered only 28 days before surgery according to the set criteria. Mircera is also freely used in the control group according to the criteria up to 7 days before KT but not used between 7 days before surgery and a day before surgery.

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.