Fisetin Impact on Stem Cell Functionality and Inflammation in Advanced Chronic Kidney Disease
This phase 2 study aims to evaluate the impact of Fisetin on reducing inflammation and improving stem cell functionality in patients with advanced chronic kidney disease, by comparing the effects of the study drug to a placebo.
Fisetin
+ Placebo oral capsule
Frailty+18
+ Urogenital Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: January 2, 2018
Actual date on which the first participant was enrolled.This study focuses on individuals with advanced chronic kidney disease, particularly those with diabetic kidney disease. It aims to understand the impact of a drug called fisetin on kidney function, inflammation, and physical function. Fisetin is a substance that may improve the function of certain stem cells in the body, potentially helping to reduce inflammation and improve kidney health. This research is important as it could lead to new treatments for chronic kidney disease, a condition that currently has limited treatment options. Participants in this study will receive either fisetin or a placebo (a substance with no active medication) for two days. They will be randomly assigned to receive either the study drug or the placebo. Over the course of 12 months, participants will have blood, urine, and skin and fat samples taken from the abdominal wall. They will also undergo tests to measure physical strength at certain times. The study's main goals are to examine the effect of fisetin (compared to the placebo) on inflammation and on the function of stem cells. These effects will be measured at the start of the study and again after 14 days.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 40 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location