Bundaberg Central

Researchers are evaluating two types of radiation treatments for women with small, node-negative breast cancer (3 cm or smaller) after breast-conserving surgery. The study aims to find out if partial breast irradiation (PBI) given once a day over one week is not worse than whole breast irradiation (WBI) in preventing cancer from coming back locally and if it leads to better cosmetic outcomes as assessed by patients three years after treatment. This is a phase 3 randomized trial focusing on the comparison of these two radiation approaches. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total radiation dose of 26 Gy divided into 5 daily sessions over 5 to 7 days (up to 8 days allowed due to holidays). The radiation is carefully targeted to the appropriate breast area, and the study is single-blinded so that patients do not know which treatment they receive to avoid bias in cosmetic assessments. Treatment planning includes using CT imaging and surgical markers for accurate delivery. During the study, participants will be monitored annually for five years to check for local cancer recurrence. Cosmetic outcomes will be assessed by patients themselves at three and five years post-treatment. Other evaluations include tumor characteristics and receptor status, and treatment safety will be observed. The total participation involves follow-up over several years to understand long-term effects of the treatments.

Researchers are investigating treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare condition affecting 1 to 2 people per 10,000. This Phase 3 global platform trial aims to gather strong evidence on how different treatments impact patients across multiple areas of care. The study uses an adaptive design, allowing changes during the trial, such as adding or removing treatment options and adjusting participant assignments based on ongoing results. The trial starts with two treatment areas: dialysis membrane types and drug therapies. In the drug therapy group, patients receive either Vitamin K1 capsules three times a week after dialysis, Magnesium Citrate tablets three times daily (with timing adjusted on dialysis days), Sodium Thiosulfate injections during the last hour of dialysis three times weekly, or matching placebos. The dialysis membrane group compares two types of dialyzers: high flux and medium cut-off. Participants will be assessed over 12 weeks using the BEAT-Calci Wound Assessment Scale, measuring wound healing progress. The study includes regular monitoring and adaptive sample size updates to determine when enough evidence is collected. The trial continues until clear results show treatment benefits or no effect, with ongoing evaluations to ensure participant safety and treatment effectiveness.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Autosomal Dominant Polycystic Kidney Disease (ADPKD) affects millions worldwide and is a leading cause of kidney failure. This research aims to evaluate whether metformin, a common diabetes medication, can be repurposed to slow kidney function decline in adults with early-stage ADPKD. The trial addresses the limited treatment options currently available and the significant impact of ADPKD on quality of life, anxiety, and depression. Participants will be randomly assigned to receive either extended-release metformin or a placebo with inactive tablets identical in appearance. This global Phase III study plans to enroll 1,174 adults aged 18 to 70 years diagnosed with ADPKD. The study will carefully monitor kidney function over 24 months to assess the effects of metformin on disease progression. During the study, participants will undergo evaluations including kidney function tests measured by estimated glomerular filtration rate (eGFR). Researchers will track changes over two years to determine if metformin slows kidney decline. Safety assessments and adherence monitoring will also be part of the study to ensure participant well-being throughout the trial period.

Kidney failure is a serious and growing health problem that requires treatment with dialysis or transplantation to prevent fatal outcomes. Haemodialysis, the most common treatment in Australia and worldwide, often causes significant burdens such as fatigue, pain, cramps, and a reduced quality of life. The early months of starting haemodialysis are particularly risky, with high mortality rates possibly linked to the sudden loss of remaining kidney function when patients begin the typical three sessions per week treatment. This trial aims to evaluate whether starting haemodialysis incrementally at two sessions per week can maintain quality of life and safety compared to the conventional thrice weekly schedule. Participants in the study will be randomly assigned to receive either incremental haemodialysis starting at two sessions per week or conventional haemodialysis starting at three sessions per week. This international, multicenter randomized trial will recruit 372 adults beginning haemodialysis for kidney failure. The study will compare the two treatment schedules over time to see if the incremental approach preserves patient health and kidney function while reducing treatment burden and costs. During the trial, participants' quality of life will be carefully assessed using kidney disease-specific questionnaires six months after starting dialysis. Researchers will monitor the safety, practicality, and cost-effectiveness of the incremental dialysis method. The study will provide important data on whether this less intensive treatment schedule can benefit patients and families by lowering physical and financial burdens, reducing early mortality, and improving dialysis capacity.

This research aims to evaluate whether lowering blood phosphate levels in people with end-stage kidney disease (ESKD) who are on dialysis can reduce the risk of death or major heart-related events compared to maintaining higher phosphate levels. The study also looks at whether lowering phosphate improves physical health, fatigue, quality of life, patient satisfaction, and itching, as well as whether it is cost-effective. Hyperphosphatemia, or high phosphate in the blood, is common in ESKD and linked to higher death risk, but there is no strong trial evidence that lowering phosphate improves important patient outcomes. Participants will be randomly assigned to one of two groups: an intensive phosphate target group aiming to keep serum phosphate at or below 1.50 mmol/L using phosphate-lowering medications, or a liberal phosphate target group aiming for a higher phosphate range of 2.0 to 2.5 mmol/L. In the liberal group, all phosphate-lowering drugs at baseline will be stopped and only restarted if phosphate rises above 2.5 mmol/L. Medication choice and doses will be based on physicians' and participants' decisions to meet target levels. The trial is multinational and will include 3600 adults on dialysis. During the study, researchers will track major outcomes including cardiovascular death or serious heart and artery events over 5 years. They will also assess physical health, quality of life using the EQ5D-5L questionnaire, fatigue, itching, and overall survival. The study involves monitoring serum phosphate levels and medication use, and measuring cost-effectiveness of the treatment strategies. Participants will be followed closely to understand the safety and impact of the phosphate targets on their health and well-being.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are studying how coronary artery plaque develops and changes over time in people with melanoma who have been treated with immune checkpoint inhibitors (ICIs). This prospective observational study aims to understand the natural progression of coronary atherosclerosis in this group. The study is being conducted at various sites across Australia and focuses on adults aged 40 years and older with melanoma at any stage who have received or are planned to receive ICI treatment. Participants will be monitored primarily for 18 months to assess the burden and composition of coronary plaque. The study involves imaging assessments, specifically coronary computed tomography angiography (CTCA), to evaluate the state of coronary arteries. No investigational treatments are administered as this is an observational study focusing on natural disease progression. During the study, participants will undergo follow-up CTCA scans and other assessments to monitor coronary artery health. Researchers will collect data on coronary plaque characteristics and progression while monitoring the participants' adherence to the protocol over the study duration. Safety and eligibility will be continuously assessed, and participants may be followed for up to 18 months to understand long-term outcomes related to coronary atherosclerosis in melanoma patients treated with ICIs.