This trial is evaluating whether Saroglitazar Magnesium 2 mg will improve 1 primary outcome and 13 secondary outcomes in patients with Fibrosis. Measurement will happen over the course of 76 Weeks/EOT.
This trial requires 240 total participants across 3 different treatment groups
This trial involves 3 different treatments. Saroglitazar Magnesium 2 Mg is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
"around 500,000 people in the United States develop kidney disease every year. Of those with kidney disease, more than 50% have an onset that is related to the course of a chronic kidney disease. The lifetime risk of developing chronic kidney disease for persons >50 years is 10.5% for men and 15.3% for women." - Anonymous Online Contributor
"Scarring from acute disease does not contribute to a cure. However, fibrosis which causes permanent damage to the lung(s) may resolve completely, and scarring may be a useful biomarker for the therapeutic monitoring of the disease. There is no evidence that scarring can be prevented or cured. This article is protected by copyright. All rights reserved." - Anonymous Online Contributor
"The cause of fibrosis is multifactorial. Some of the known triggers are the immune system and inflammatory mediators, and exposure to environmental toxicants, medications, and genetic abnormalities. Fibrosis is characterized by chronic inflammation with consequent thickening of the lung tissues, due to overproduction of proteins by cellular activation, proliferation, and fibrogenic gene expression." - Anonymous Online Contributor
"The signs of cirrhosis of the liver include symptoms such as fatigue, easy bruising\ninability to drink or walk for prolonged periods of time, swollen hands or feet, and jaundice. Other signs include an increase in production of stools (abnormal gut sounds on a stethoscope), poor appetite and unintentional weight loss. The liver does not produce erythrocytes, so signs of anemia are not common. Chronic liver disease can result in other signs or symptoms including itching ("pruritus"), dark, tarry urine ("hematuria") and jaundice ("icterus")." - Anonymous Online Contributor
"The use of a variety of treatments for the management of Fibrosis involves the treatment of both the symptoms and the underlying cause. Treatment options include medical and surgical therapy. Treatments may not necessarily be applicable to every patient with fibrosis." - Anonymous Online Contributor
"Fibrosis can occur in various locations of the body, most commonly in the liver, but also in almost any part in which the vascular supply is compromised.\n" - Anonymous Online Contributor
"Saroglitazar sodium or magnesium were well tolerated at 2 mg doses. On the basis of this pooled analysis and the tolerability profile of saroglitazar in the trials presented in this paper, saroglitazar magnesium is a favorable option for the treatment of NAFLD." - Anonymous Online Contributor
"The current meta-analysis adds the efficacy and safety information to the existing saroglitazar monotherapy efficacy evidence, suggesting that saroglitazar monotherapy is both effective and tolerable in a clinical scenario." - Anonymous Online Contributor
"Fibrosis is less common than was previously thought. The mean age of onset is 55.5 years. There does appear to be a slight difference in the average age of diagnosis by gender, with the mean age of diagnosis by gender being 64 years per male and 67 years per female. The mean age of diagnosis was 63 years for both the male and female patients undergoing liver fibrosis. The mean age of diagnosis for both males and females was 53.9 and 55.8 years respectively." - Anonymous Online Contributor
"Recent findings of this preliminary study suggest that saroglitazar Mg 2 mg is safe when prescribed appropriately by experienced personnel to people that are receiving corticosteroids therapy post myocardial infarction." - Anonymous Online Contributor
"Fibrosis is classified into four broad categories with a variety of etiologies: idiopathic (idiopathic lung fibrosis, idiopathic heart fibrosis, and idiopathic liver fibrosis), idiopathic-type pulmonary fibrosis (Idi-iphotoxic pulmonary fibrosis), infectious/inflammatory, or radiation/chemical induced. Of these, idiopathic-fibrosis of the lungs represents the largest cause, [approximately 80% of all idiopathic fibrosis cases] [Power (https://www.withpower.com/d/fibrosis) has specific clinical trials for many of the fibrosis diseases." - Anonymous Online Contributor
"[Appendicular fasciitis, fatigue, and dizziness>occur in>30% of subjects given saroglitazeremagnesium 2 mg per day for 4 weeks in clinical studies]<\n[Appendicular fasciitis, fatigue, and dizziness] occurred in<30% of subjects given saroglitazaremagnesium 2 mg per day for 4 weeks in clinical studies]." - Anonymous Online Contributor