Whangarei

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

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.

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 a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.

Chronic kidney disease (CKD) affects over 800 million people worldwide and is expected to become the 5th leading cause of death by 2040. CKD progresses to kidney failure, increases risks of early death and heart disease, and reduces quality of life. Current treatments do not fully prevent kidney failure, so this trial aims to find the best treatment or combination of treatments to slow CKD progression. CAPTIVATE is a Phase III, international, multi-center, adaptive platform trial designed to answer multiple treatment questions efficiently within a single research framework. Participants receive study treatments, such as Finerenone or placebo tablets taken orally once daily, for two years. They may be involved in more than one treatment at the same time or at different times. Follow-up visits occur around 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment, with a final visit one month after treatment ends. The trial is ongoing and flexible, allowing new treatments to be added or removed based on results. During the study, participants have blood and urine tests, safety assessments, and treatment adherence monitoring. Health information is collected at study visits and every five years to evaluate long-term outcomes. The main measurement is the change in kidney function (eGFR slope) from the start of treatment to week 108. The study continues recruiting participants for many years to improve CKD treatment options.

Researchers are evaluating whether an early three-day course of oral dexamethasone can improve recovery and wellbeing in children aged 4 to 17 years with Sydenham's chorea, a movement disorder caused by inflammation in the brain after a Group A streptococcus infection. This condition affects children's movements, mood, and concentration, and can take months to fully recover from. The study is a randomized, double-blinded, placebo-controlled phase 3 trial conducted in New Zealand and Australia, focusing on reducing symptoms and improving mental health outcomes. Participants will be randomly assigned to receive either oral dexamethasone suspension at a dose of 20mg/m2/day (up to 24mg/day) divided into three doses daily for three days, or matching placebo capsules taken three times daily for the same duration. The study compares the effects of this short steroid course against placebo to determine safety and effectiveness in treating Sydenham's chorea. The trial plans to enroll 80 children from multiple hospital sites. During the study, children's chorea severity and psychiatric symptoms will be assessed at one, three, and twelve months using standardized rating scales and questionnaires. Safety checks for adverse events related to dexamethasone will occur on days three, seven, and at one month. Additional outcomes include relapse rates, hospital length of stay, and treatment failures. The total follow-up period spans a year to monitor both physical and mental recovery.

This research evaluates the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instruments in patients undergoing primary or revision shoulder arthroplasty. The study includes individuals with shoulder conditions such as fractures, arthritis, osteoarthritis, deformity, injuries, and pain. It aims to confirm these outcomes using standard scoring systems, X-ray evidence, and tracking of any adverse events related to the implants. Participants receive the Zimmer Biomet shoulder devices, specifically the Alliance Glenoid and Identity Stem, which are used in various types of shoulder arthroplasty including total shoulder replacement and hemi-arthroplasty. The study monitors implant survival over 10 years, looking at whether any implant parts need removal, while also analyzing safety by recording adverse events. Performance and clinical benefits, including pain, function, quality of life, and radiographic results, are assessed at 2 years post-implantation. During the study, participants will undergo regular assessments including clinical scoring, imaging, and safety monitoring to track implant survivorship and any complications for up to 10 years. Researchers will evaluate shoulder function, pain levels, and quality of life using established scores. Long-term follow-up ensures ongoing safety and effectiveness data are collected, supporting comprehensive understanding of the implant system over an extended period.