Jaffna

Researchers are evaluating the safety and effectiveness of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international, randomized, double-blind, placebo-controlled Phase 3 trial aims to understand how finerenone affects morbidity and mortality in this patient group. Participants will receive either oral finerenone or a matching oral placebo. The study focuses on patients currently hospitalized or recently discharged with heart failure symptoms and specific heart function measures. The trial is event-driven and will continue for up to approximately 30 months to collect sufficient data on outcomes. During the study, researchers will monitor the total number of heart failure events and cardiovascular deaths, as well as track serious adverse events and any adverse events that lead participants to stop the study drug. These ongoing assessments will help evaluate the overall safety and impact of the treatment over the duration of the trial.

Researchers are conducting a multinational, prospective observational study called the ICU-related Out-of-Pocket Expenses (ICOPE) study in African and Asian countries. This study aims to measure the financial burden on patients and families related to ICU care, focusing on out-of-pocket expenses and catastrophic health expenditure. The study includes both ventilated and non-ventilated patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. Participants are followed during their ICU stay, which averages about 7 days, and additional follow-ups occur at 30 days and 6 months after admission. The study compares costs between patients receiving invasive mechanical ventilation and those who are not ventilated. It also investigates risk factors for catastrophic health expenditure and documents how families cope with the financial demands of ICU care. Throughout the study, researchers collect data on patient expenses, including direct medical and non-medical costs, as well as indirect costs such as income loss. The main outcomes measured are the out-of-pocket cost per patient episode until ICU discharge and the relative risk of catastrophic health expenditure. The total study duration spans 18 months, allowing for comprehensive assessment of financial impact and coping strategies over time.

Researchers are evaluating the effects of the SGLT2 inhibitor dapagliflozin compared to metformin on the annual decline in kidney function measured by eGFR in people with Type 2 Diabetes. This Phase 3 randomized, double-blinded clinical trial is conducted in primary care and community settings in Australia and in tertiary care centers in Sri Lanka. The study aims to determine how these medications perform as first-line therapies to prevent kidney decline in this population. After a 4-week active run-in period, eligible participants will be randomly assigned in equal numbers to receive either dapagliflozin 10 mg daily or metformin extended-release 2000 mg daily. Both medications are taken orally and are compared directly to assess their impact on kidney health over time. Participants will be involved in the study for at least 24 months, during which their kidney function will be regularly monitored to measure the rate of decline in eGFR. The study includes safety assessments and ongoing evaluations to ensure participant well-being and to measure the effectiveness of the treatments in slowing kidney decline associated with Type 2 Diabetes.

Researchers are evaluating the safety, effectiveness, behavior in the body, and biological effects of WAL0921 in adults with certain glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to better understand how WAL0921 works and its safety profile in these patients. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. After the treatment period, all participants will be monitored for an additional 24 weeks to observe any long-term effects. The study setup allows comparison between the investigational drug and placebo to assess treatment impact. During the study, participants will be closely monitored for any treatment-related side effects from the start of the study through week 36. Regular assessments will include safety checks and evaluations to track how the drug affects their condition. This monitoring aims to ensure participant safety and to measure important outcomes related to kidney health and proteinuria over the entire study period.