Colombo

Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

This research aims to evaluate the potential of transferring mitochondria from a womans own adipose stem cells to her oocytes during intracytoplasmic sperm injection ICSI to improve embryo development and increase the success rate for women who have experienced multiple failed IVF attempts. Embryo quality is crucial for successful assisted reproductive technologies, and factors such as age and genetics can affect this. Since oocytes depend heavily on mitochondria for energy, boosting mitochondrial content may enhance embryo quality in patients with repeated IVF failures. In this study, mature sibling oocytes will be randomly divided into two groups. One group will undergo conventional ICSI, while the other group will receive mitochondria transplanted from adipose-derived stem cells together with ICSI called Mito-ICSI. Viable blastocysts from both groups will be biopsied for genetic testing to check for chromosome abnormalities. This randomized, double-blind study compares the outcomes of these two approaches. Participants will provide adipose tissue samples through subcutaneous liposuction and consent to have all embryos frozen and biopsied for genetic testing. Researchers will monitor embryo development rates up to 8 weeks after the procedure and track pregnancy outcomes, such as clinical pregnancy rates, live births, and complications, over up to 24 months. The study involves close monitoring and assessments to evaluate the effects of the mitochondrial transfer on embryo quality and pregnancy success.

Researchers are evaluating the safety and tolerability of Empagliflozin, with or without metformin, in patients with Type II Diabetes Mellitus within the Pakistani population. This open-label, prospective, observational, single-arm, multi-center post-marketing surveillance study aims to monitor side effects such as hypoglycemia, dehydration, urinary tract infections, and gastrointestinal symptoms. The study is sponsored by Getz Pharma and includes adults aged 18 to 65 years with uncontrolled diabetes despite oral antidiabetic treatment and lifestyle modifications. Participants will receive Empagliflozin alone or combined with metformin in varying doses. The study includes three follow-up visits after starting therapy the first at 4 to 6 weeks, the second at 12 weeks, and the third at 24 weeks. Laboratory tests such as HbA1c, fasting blood glucose, renal function tests, and urine routine examination will be conducted at reputable clinical labs, with participants receiving discounts for these tests. During the study, participants will be closely monitored for safety and efficacy outcomes over six months from enrollment. Assessments include clinical evaluations and laboratory investigations to track diabetes control and potential side effects. The total study duration is 12 months, with the primary outcomes focusing on safety and tolerability at six months and secondary outcomes on efficacy. Participants health will be carefully observed throughout the follow-up period.

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-blind trial is conducted in primary care and community sites in Australia and tertiary care centers in Sri Lanka. The purpose is to understand which first-line therapy may better prevent kidney decline in this population. After a 4-week active run-in period, participants will be randomly assigned to one of two groups one group will take dapagliflozin 10 mg once daily with placebo metformin tablets, and the other group will take metformin XR 2000 mg once daily with placebo dapagliflozin tablets. Treatment will continue for 2 years under quadruple masking to maintain study integrity. During the study, participants will undergo assessments including kidney function tests eGFR, serum creatinine, urine albumin creatinine ratio, blood sugar measurements HbA1C, fasting glucose, blood pressure monitoring, body weight check, and quality of life evaluations using the EQ-5D-5L. Mental health symptoms such as anxiety and depression will also be measured with the HADS questionnaire. The primary outcome is the rate of eGFR decline over 24 months, with safety and other health indicators monitored throughout the study period.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

Chronic kidney disease CKD affects over 800 million people worldwide and is expected to become the fifth leading cause of death by 2040. This trial investigates various treatments to find the best options or combinations that slow CKD progression and reduce the risk of kidney failure and related complications. The study is a Phase III, international, multi-center, adaptive, platform trial designed to answer multiple treatment questions efficiently within a common setup. Participants receive study treatments, such as finerenone tablets 10mg or 20mg or matched placebo tablets, taken orally once daily. Each treatment period lasts 2 years, with follow-up visits scheduled at about 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment. A final visit occurs one month after completing the 2-year treatment phase. The trial is ongoing and allows participants to join multiple treatment arms either simultaneously or at different times. During the study visits, researchers collect blood and urine tests, evaluate safety, and monitor treatment adherence. Overall health status is assessed every 5 years. The main outcome measured is the change in kidney function eGFR slope from the start of treatment to week 108. Secondary outcomes include changes in albuminuria, kidney failure events, mortality, cardiovascular events, safety, and quality of life. The trial plans long-term follow-up and safety monitoring over several years.