Kidney Failure

This research evaluates how well furosemide alone compares to furosemide combined with albumin in critically ill adults who have fluid overload. The study aims to find out if adding albumin improves urine output and kidney function markers compared to using furosemide by itself. Key measurements include urine output two hours after treatment, kidney blood flow indicators, and various biochemical tests. Participants are randomly assigned to receive either furosemide at 1 mg per kg of body weight intravenously over 30 minutes with a placebo, or the same dose of furosemide together with 50 grams of 25% albumin infused over 30 minutes. The study uses bedside ultrasound to assess fluid overload signs and monitors blood pressure, electrolytes, and kidney filtration rates during the trial. During the study, participants undergo urine output measurement at two hours and blood tests to track changes in kidney function and electrolyte levels up to 24 hours after treatment. Ultrasound evaluations assess vein size and congestion at baseline and after two hours. Researchers monitor safety and response to treatment while collecting data on urine volume and kidney health markers to understand the impact of adding albumin to furosemide therapy.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are evaluating TS-172 in adults with hyperphosphatemia who are receiving hemodialysis due to chronic kidney disease. This open-label, single-arm clinical study aims to assess how well TS-172 controls serum phosphorus levels in this patient group. The study is sponsored by Taisho Pharmaceutical Co., Ltd. and focuses on patients who have been on hemodialysis three times a week for at least 12 weeks. Participants will receive oral TS-172 once daily at doses ranging from 20 to 60 mg. The study monitors the achievement rate of target serum phosphorus levels by Week 8. Secondary measures include changes in serum phosphorus concentration, corrected serum calcium levels, and the serum calcium-phosphorus product up to Week 8. During the study, participants will undergo regular blood tests to measure phosphorus and calcium levels and monitor parathyroid hormone concentrations. Researchers will track changes from baseline to evaluate treatment effects. The study does not involve blinding or placebo groups. Participants will be followed from screening through Week 8 to assess safety and efficacy outcomes.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are studying how the drug MK-2828 behaves in the body over time, focusing on people with different levels of kidney disease compared to healthy individuals. This Phase 1 trial aims to understand the drugs pharmacokinetics, or how it is absorbed, distributed, metabolized, and eliminated in people with severe renal impairment, end-stage renal disease ESRD on hemodialysis, and healthy controls. Participants are divided into three groups based on kidney function. Those with severe renal impairment receive a single oral dose of MK-2828 on Day 1. Participants with ESRD on hemodialysis receive a single dose on Day 1 during two separate periods, with at least a 14-day break between doses. Healthy participants with normal kidney function also receive a single dose on Day 1. This open-label study does not involve randomization or blinding. During the trial, participants undergo blood sampling before dosing and at several time points up to 192 hours after receiving MK-2828 to measure drug concentrations and pharmacokinetic parameters. For those on hemodialysis, additional measurements related to dialysis clearance are collected up to 6 days. Safety is monitored by tracking adverse events for about two weeks. Participation lasts a few days depending on the dosing schedule and required sampling times.

Researchers are evaluating the use of sodium zirconium cyclosilicate SZC to help optimize renin-angiotensin aldosterone system inhibitor RAASi therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Researchers are evaluating a communication-priming intervention called CKD Jumpstart- Tips aimed at improving shared decision-making between older adults with advanced chronic kidney disease CKD and their clinicians. This cluster-randomized controlled trial focuses on patients with CKD Stage 4 or 5, seeking to enhance communication quality, patient involvement, decisional conflict, decision regret, timing and adherence to treatment choices, and health-related quality of life. The study compares two groups one receiving the CKD Jumpstart- Tips intervention and the other receiving usual care. Patients in the intervention group complete the priming tool before a target clinic visit and receive a summary sheet with communication tips and survey responses to share with their healthcare team. Clinicians also receive a priming sheet with tailored communication guidance based on patient responses. Additional educational materials on kidney failure treatment options are available as part of routine care. Participants will be assessed immediately after the target visit and followed for up to six months. Evaluations include observer-rated and patient-reported shared decision-making, quality of communication, consultation length, patient involvement, decisional conflict and regret, timing and adherence to treatment, and health-related quality of life. The study aims to measure the impact of the communication intervention on these outcomes while monitoring patient experience and treatment decisions over time.

This research aims to compare two timings of physical therapy for adults with end-stage renal disease ESRD who are undergoing hemodialysis. The study evaluates whether exercising during dialysis sessions or before dialysis leads to better improvements in physical function, quality of life, and laboratory measures such as hemoglobin and electrolyte levels. A total of 72 adult participants will take part in this randomized controlled trial to help determine the best approach to physical therapy in this population. Participants will be randomly assigned to one of two groups. One group will perform supervised physical therapy exercises during their dialysis sessions twice weekly for 12 weeks, while the other group will perform the same exercises before their dialysis sessions on the same schedule. Each session lasts about 30 minutes and includes warm-up, resistance training, and cool-down. Both groups will first receive standardized education about the benefits and safety of exercise before starting the intervention. Throughout the study, participants will undergo assessments including the Six-Minute Walk Test, Five Times Sit-to-Stand Test, and quality of life questionnaires at baseline, every four weeks during the 12-week intervention, and at a 6-month follow-up. Blood tests to measure hemoglobin and electrolyte levels will be done at baseline and at 4, 8, and 12 weeks. The study monitors these outcomes to evaluate the effects of exercise timing on health and well-being for individuals on hemodialysis.

Researchers are evaluating the use of Near Infrared Spectroscopy NIRS to predict acute kidney injury AKI in adult patients undergoing cardiac surgery with cardiopulmonary bypass. AKI is a common and serious complication after such surgeries, leading to increased hospital stays, costs, and mortality. This study aims to compare the effectiveness of NIRS sensors placed on the skin over the kidney versus sensors placed on the limbs for predicting AKI. The research is conducted by the University of Utahs anesthesiology department. Participants will have NIRS sensors placed on the skin over their kidney, as located by ultrasound, and on the muscles of their arm and thigh before surgery. If a patient has had a right nephrectomy, the sensor will be placed over the left kidney. Additional sensors will be placed on the forehead to measure brain oxygen levels during surgery. The study observes how well these sensor placements predict AKI from the day of surgery up to seven days afterward. During the study, participants will undergo ultrasound measurements to determine the depth of kidney and muscle tissue before sensor placement. Researchers will monitor oxygen levels in various tissues throughout surgery and track outcomes such as AKI development, ventilator times, length of hospital stay, and in-hospital mortality up to three months. Hemodynamic data including blood pressure, oxygen delivery, vasopressor use, and anemia during surgery will also be recorded. The total observation period extends from surgery through hospital discharge and follow-up for up to three months.

Researchers are evaluating whether using an automated Carbon Dioxide CO2 injection system during infrainguinal peripheral vascular interventions PVI can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury CA-AKI. This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.