Colombo

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.

This research aims to explore the use of autologous adipose stem cell (ASC) mitochondrial transfer combined with intracytoplasmic sperm injection (ICSI) to improve embryo development in women who have experienced multiple IVF failures. Embryo quality is critical for successful assisted reproductive technologies and can be affected by factors such as age, genetics, and physiological conditions. Since oocytes depend heavily on mitochondria for energy, insufficient mitochondrial function has been linked to poor embryo outcomes, and increasing mitochondrial mass may enhance embryo quality in this group of patients. During the study, mature sibling oocytes will be randomly divided into two groups. One group will receive conventional ICSI (control group), while the other group will undergo mitochondrial transfer from adipose stem cells along with ICSI (referred to as ASCENT). Viable blastocysts from both groups will be biopsied for preimplantation genetic testing to check for chromosomal abnormalities. Participants will be involved in consenting to specific procedures including biopsies, single blastocyst transfer, freezing all embryos, and adipose tissue collection through liposuction. Researchers will monitor embryo development rates up to 8 weeks after intervention, assessing embryo quality and genetic status. The study focuses on women aged 29 to 39 with a history of recurrent IVF failures, with careful evaluation of treatment effects and safety throughout the process.

Researchers are evaluating the safety and tolerability of Empagliflozin, with or without metformin, in adults aged 18 to 65 years who have Type II Diabetes Mellitus in the Pakistani population. This Phase 4, open-label, prospective, observational study involves 156 patients and aims to monitor common side effects such as hypoglycemia, dehydration, urinary tract infections, fungal infections, nausea, and abdominal discomfort. The study focuses on patients who have not previously used Empagliflozin and have uncontrolled diabetes despite oral antidiabetic medications and lifestyle changes. Patients must have HbA1C levels between 7% and 10% and an estimated glomerular filtration rate (eGFR) of 60 or above. Participants will receive Empagliflozin either alone or combined with Metformin in various dose combinations. The drug doses include Empagliflozin plus Metformin combinations of 5mg/500mg, 5mg/850mg, 5mg/1000mg, 12.5mg/500mg, 12.5mg/850mg, and 12.5mg/1000mg, or Empagliflozin alone at 10mg or 25mg. The study spans 12 months, with safety data collected through a 6-month follow-up period after the last patient's enrollment. Follow-up visits occur at 4 to 6 weeks, 12 weeks, and 24 weeks after starting treatment. During the study, patients will undergo laboratory tests including HbA1C, fasting blood glucose, renal function tests, and urine routine examinations to monitor diabetes control and kidney health. Certified clinical labs will analyze these samples, and patients receive up to 50% discount on study-related lab tests. Researchers will closely watch for adverse effects and treatment tolerability throughout the visits, ensuring patient safety and gathering real-world evidence on the treatment's impact over six months.

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.

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.