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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.
Actively Recruiting
Researchers are studying complex renal cysts, specifically Bosniak III and IV cysts, which are common among individuals aged over 60 years. These cysts are traditionally treated with surgery due to concerns about malignancy, but recent evidence suggests many may be benign or have low risk of spreading. This observational study aims to compare long-term cancer-specific survival over five years between patients managed with active surveillance and those who undergo surgery, to better understand which approach is safer and more effective. Participants will choose either active surveillance or surgery as their management strategy. The active surveillance group will be closely monitored with abdominal imaging ultrasound, CT, or MRI, chest X-rays or CT scans, and blood tests every six months for the first three years and annually thereafter. The surgery group will receive treatment as per standard care, which may include partial or total kidney resection or thermoablation. Both groups will be followed for up to five years to assess outcomes. During the study, participants will have regular research visits to assess their vital status and quality of life using validated questionnaires. Those under active surveillance will be monitored for cyst progression and may receive further therapy if needed. Researchers will measure cancer-specific survival, overall survival, tumor progression, quality of life changes, anxiety, and healthcare costs. The study will last up to five years, providing a comprehensive evaluation of these two management options.