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Fenofibrate for Type 1 Diabetes (PERL-FENO Trial)
PERL-FENO Trial Summary
This trial is to test whether the generic drug fenofibrate can prevent kidney damage in people with type 1 diabetes. 40 participants will be enrolled and given either fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and end of the study.
PERL-FENO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPERL-FENO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 551 Patients • NCT03001817PERL-FENO Trial Design
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- I have had gallstones but my gallbladder has been removed.Your hemoglobin (a protein in red blood cells) level is too low (less than 11 g/dL for males, less than 10 g/dL for females) or your platelet count is too low (less than 100,000/mm3) at the time of screening.My kidney disease is not caused by diabetes.I have diabetic kidney disease at high risk of worsening.I am currently taking medication that affects fat metabolism.You are allergic to fibrates or substances containing iodine.I have had pancreatitis, DVT, or a pulmonary embolism in the past.You have had type 1 diabetes for at least 8 years.My kidney function, measured by eGFR, is between 40 and 99.9.I am not pregnant, breastfeeding, and agree to use contraception during the trial.I haven't had cancer treatment (other than for non-melanoma skin cancer) in the last 2 years.I was diagnosed with type 1 diabetes after age 35 and have documentation of it.I have had a kidney transplant or am on dialysis.I am currently taking a RAS blocker, unless it's not recommended for me.I cannot take fibrates due to specific health reasons.I have serious health issues besides diabetes.I am between 18 and 70 years old.You have abused alcohol or drugs in the last 6 months.I have or had severe liver damage.I have a history of AIDS or HIV infection.You have donated blood within the past 3 months.I have had a skin rash or muscle inflammation caused by light.I have Type 1 diabetes and started insulin within a year of diagnosis.You need to have a recent test to measure your kidney function.Your blood test shows high levels of creatinine phosphokinase without a clear reason.
- Group 1: Fenofibrate
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is it possible to be admitted as a participant in this research study?
"To be accepted into this trial, applicants must have diabetic nephropathies and fall in the age range between 18 to 70 years old. The total slots for participants are estimated at 40 individuals."
How many participants have signed up for the experiment thus far?
"Affirmative. According to the clinicaltrials.gov entry, this research trial is presently looking for enrolment from volunteers. The experiment was first posted on April 1st 2022 and has been recently updated as of August 15th 2022; 40 individuals across two locations are currently called for in the study."
What symptoms does fenofibrate typically ameliorate?
"Fenofibrate has been demonstrated to be efficacious in the management of hypertriglyceridemia, especially severe fredrickson type v hypertriglyceridimia and dyslipidemias."
What is the intended outcome of this clinical experiment?
"The primary aim of this research, with data collection taking place over 84 weeks after patient randomization, is to evaluate the Baseline-adjusted levels of serum biomarkers that can indicate an increased risk for end-stage kidney disease (ESKD). Secondary objectives include measuring a Glomerular filtration pressure at 8 weeks post-randomization via para-aminohippurate infusion and adjusting it by its baseline value; charting GFR estimated from serum creatinine using the CKD-EPI equation; as well as evaluating Baseline-adjusted glomerular oncotic pressure at 8 weeks following randomization."
Are there any current opportunities for individuals to take part in this research?
"This medical trial is currently open for recruitment and the details have recently been revised as of August 15th, 2022. It was initially posted on April 1st, 2022."
Does this investigation accept participants aged 65 or above?
"To participate in this clinical trial, all applicants must be between the ages of 18 and 70. Separately, there are 148 trials for patients younger than 18 years old, as well as 214 separate studies for persons over 65."
What potential health risks are associated with Fenofibrate use?
"Due to a dearth of data on fenofibrate's efficacy, it has been assigned an interim safety rating of 2."
Could you provide details on the prior research concerning Fenofibrate?
"Fenofibrate was initially studied in 2009 at the University of Ioannina Medical School, and since then 18400 trials have been successfully completed. At present there are 8 active experiments taking place across multiple states, with a major portion being conducted out of Ann Arbor, Michigan."
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