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Kidney Failure, Chronic clinical trials

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NCT ID: NCT06040684 Completed - Kidney Failure Clinical Trials

Development of Antibodies Against Transplant Kidney After Infection

Start date: August 1, 2018
Phase:
Study type: Observational

Kidney transplantation is the best method of renal replacement in patients with irreversible renal failure. One of the biggest problems today is premature loss of function of the transplanted kidney. This occurs most often on the basis of chronic humoral rejection. This is the immune response to the kidney, in which the specific antibodies play a crucial role (both against the HLA and the non-HLA system). The aim of this study is to analyze one of the situations where the production of antibodies can begin to occur. This is a serious acute infection (bacterial, viral, or fungal), where it is necessary to significantly reduce doses of immunosuppressives. At the time of reduced immunosuppression, the immune system can recognize the transplanted kidney as foreign to the human body and begin to fight against it. In this study, the investigators will monitor antibodies against the transplanted kidney in patients with severe acute infection. A serious infection in this study is one that requires acute hospitalization and reduced doses of immunosuppressive drugs. The researchers will measure the antibodies in the blood upon admission and then in 5 weeks.

NCT ID: NCT05943977 Completed - Kidney Diseases Clinical Trials

A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants

Start date: March 2, 2023
Phase: Phase 3
Study type: Interventional

Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants.

NCT ID: NCT05769595 Completed - Clinical trials for Kidney Failure, Chronic

Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

Start date: June 14, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.

NCT ID: NCT05718765 Completed - Physical Activity Clinical Trials

The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795). The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.

NCT ID: NCT05697458 Completed - Kidney Failure Clinical Trials

Vascular Calcifications in Kidney Transplant Recipient

Start date: December 1, 2022
Phase:
Study type: Observational

Kidney transplant candidates undergo extensive diagnostic evaluation aimed at assessing their cardiovascular (CV) risk, which remains the leading cause of disability and death in this patient population. This includes among others an assessment of the iliac arterial calcification. Chronic kidney disease (CKD) patients have an increased incidence of arterial calcifications due to many factors, such as increased age, hyperparathyroidism, diabetes mellitus and hypercholesterolemia. Furthermore, the severity of pelvic arterial calcifications may impact the surgical planning of kidney transplantation (KT), choice of anastomosis site, complexity of the surgery, and patient and graft survival. Vascular calcifications are recognized as a good biomarker of overall cardiovascular burden. Although computerized tomography (CT) is the imaging modality of choice for calcification evaluation, compared to pelvic X-ray and Doppler ultrasound, it is not officially included in the guidelines of different international associations, which offer general recommendations for the assessment of iliac vessels. Nevertheless, centers are increasingly using CT in their pretransplant workup, either routinely or only in patients with increased CV risk. Also, impaired bone metabolism and its consequences have an important role in the development of vascular calcification. The investigators will determine the relationship between calcification burden of iliac arteries which will be assessed on CT and the serum level of bone remodeling biomarkers, including parathyroid hormone, (PTH), calcium, phosphates, OPG/RANK/RANKL (engl. osteoprotegerin/receptor activator of nuclear factor (NF)-κΒ/RANK ligand) and Gla-Rich protein (GLP). According to investigator knowledge, this will be the first prospective study that will correlate the degree of iliac arteries calcification based on CT analyses with the serum level of various bone remodeling markers, and their impact on clinical outcome in kidney transplant recipients. The investigators expect this research to improve insights into incidence and distribution of iliac artery calcifications in patients following kidney transplantation, their correlation with clinical data and bone remodeling markers and confirm the appropriateness of using computerized tomography in a routine pretransplantation work-up.

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: 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.

NCT ID: NCT05272800 Completed - Kidney Failure Clinical Trials

BIS-guided Fluid Management in HD Patients

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Hemodialysis (HD) is life-sustaining in kidney failure. However, adequate fluid status depends on precise estimation of dry weight (DW), which is a goal difficult to achieve. This randomized open label controlled parallel-group trial aims to compare spectroscopy bioimpedance (BIS) guided DW estimation with clinical evaluation alone. Maintenance HD patients above 18 years old were randomized to monthly clinical evaluation (CE) alone or added to twice a year BIS-guided DW estimation. Randomization was performed through random number table. Follow-up lasted up to two years. Primary outcome was survival time and secondary outcomes were rate of hospital admissions, systolic and diastolic blood pressure (BP) change and number of prescribed antihypertensive drugs.

NCT ID: NCT05165173 Completed - Clinical trials for Kidney Failure, Chronic

Almond Milk With Vitamin D: Impact on Vitamin D Status

Start date: May 22, 2023
Phase: N/A
Study type: Interventional

The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.

NCT ID: NCT04818151 Completed - Clinical trials for Kidney Failure, Chronic

Anticoagulation Strategies for Acute Venous Thromboembolism in Patients With End-Stage Renal Disease Using USRDS Data

Start date: January 1, 2021
Phase:
Study type: Observational

Patients with end stage renal disease (ESRD) are at significantly increased risk of thrombosis and bleeding relative to those with normal renal function which makes anticoagulation particularly challenging. Further, ESRD patients undergoing initiation of anticoagulation for acute VTE are often kept in the hospital for heparin "bridging" which may lead to a protracted length-of-stay (LOS) and may place patients at risk for hospital-associated complications. The advent of direct oral anticoagulants (DOACs) has offered physicians choices in the management of venous thromboembolism (VTE). However, evidence suggests that rivaroxaban and dabigatran are associated with a higher risk of bleeding in ESRD patients. In contrast, research suggests that apixaban may be safer in patients with ESRD, and recent evidence suggests lower bleeding rates in ESRD patients treated for atrial fibrillation with apixaban compared to those treated with warfarin. However, to date, no large national cohort studies have examined the safety, effectiveness, and healthcare utilization of apixaban in patients with ESRD who have acute VTE. The investigators propose to use the Standard Analytic Files from the United States Renal Data System (USRDS) for years 2014 through 2018 to evaluate the safety, effectiveness, and healthcare utilization of ESRD patients initiated on apixaban compared to those initiated on warfarin (following heparin) to treat acute VTE.