Chronic Kidney Disease (CKD)

Researchers are evaluating the effects of furosemide alone compared to furosemide combined with albumin in adult critically ill patients with fluid overload. The study aims to find out if adding albumin improves urine output and kidney function. The primary focus includes measuring urine output at 2 hours and examining changes in kidney blood flow markers and biochemical tests. Secondary measures include blood pressure, electrolyte levels, and kidney resistance patterns. Participants are randomly assigned to one of two groups: one receives a single intravenous dose of furosemide at 1 mg/kg infused over 30 minutes with a placebo saline infusion, while the other receives the same dose of furosemide combined with 50 grams of 25% albumin infused over 30 minutes. This double-blind trial ensures both groups are treated under similar controlled conditions to compare the treatments effectively. During the study, urine output is measured at 2 hours after treatment administration. Researchers also use bedside ultrasound to assess fluid overload and venous congestion, while monitoring blood pressure, electrolyte changes, and kidney function through blood and urine tests up to 24 hours. The study helps determine whether albumin enhances diuretic response and kidney health in this patient group. Participation lasts through these initial assessments and monitoring periods.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

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 the efficacy and safety of BAT4406F injection in adults aged 18 to 75 years diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. This phase II/III, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how this treatment may impact these kidney conditions, which cause nephrotic syndrome and respond to corticosteroid therapy. Participants will be randomly assigned to receive one of three treatments: a single-dose BAT4406F every six months, a double-dose BAT4406F every six months, or a placebo. In Phase II, dosing involves a single dose on Day 1 or doses on Day 1 and Day 15. In Phase III, the dosing schedule depends on Phase II results and may include doses on Day 1, Day 15, Day 182, and Day 196. All doses are administered by intravenous infusion. During the study, participants will undergo assessments to monitor kidney function, disease remission status, and safety over 26 weeks in Phase II and 52 weeks in Phase III. Researchers will measure effectiveness indicators and monitor for side effects. The study includes careful screening and follow-up visits, with the total participation lasting up to 52 weeks depending on the phase.

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.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating the pharmacokinetics, or how the body processes, of one or two doses of the drug MK-2828 in people with kidney disease. The study aims to determine if the way MK-2828 behaves in individuals with certain types of kidney impairment is similar to that in healthy people. This research is a Phase 1 clinical trial focusing on participants with severe renal impairment, end-stage renal disease (ESRD), and healthy controls. Participants with severe renal impairment will receive a single oral dose of MK-2828 on Day 1. Those with ESRD on hemodialysis will receive a single dose in each of two study periods, separated by at least 14 days. Healthy participants with normal kidney function will receive a single dose on Day 1. The trial is open-label, meaning all participants and researchers know which treatment is given. During the study, participants will have blood samples collected before dosing and at various times up to 192 hours afterward to measure drug levels and related pharmacokinetic parameters. Those on hemodialysis will have additional assessments related to dialysis clearance. Safety will be monitored through tracking adverse events up to approximately 14 days. The study will continue until July 2026, with participants involved in a single-dose administration and follow-up sampling and observation.

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 the effects of intensive weight loss treatment on renal outcomes in patients with diabetic kidney disease (DKD), particularly focusing on those with rapidly progressing diabetic nephropathy. The study aims to establish a patient group receiving such treatments and to develop a prediction model for kidney health improvements following weight loss. Participants are divided into two groups: one receiving bariatric surgery, which includes laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on beta-cell function, and another group receiving non-surgical therapy comprising diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. The study monitors outcomes at 1, 3, 6, and 12 months after intervention. During the study, participants will have regular assessments measuring total weight loss, kidney function markers such as serum creatinine and glomerular filtration rate, various blood glucose parameters, waist and hip circumference, urinary microalbumin, other urine tests, and medication status. These evaluations help track the impact of the treatments on kidney health and metabolic control over the course of one year.

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.