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Thiazolidinedione
Pioglitazone for Chronic Kidney Disease
Phase 4
Recruiting
Led By Paul J Fadel, PhD
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CKD patients classified as Stage 3 and 4 of National Kidney Foundation Classification with estimated glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) formula based on serum creatinine, age, gender, and race.
Men and women 35 to 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial will test whether a drug used to improve blood sugar control can also reduce the risk of heart disease in patients with chronic kidney disease.
Who is the study for?
This trial is for men and women aged 35-70 with moderate to severe chronic kidney disease (stages 3 and 4). Participants should have a certain level of kidney function based on lab tests. People with heart failure, current smokers, those allergic to Glitazones, or with recent serious health issues like myocardial infarction or liver disease are not eligible.Check my eligibility
What is being tested?
The study is testing if Pioglitazone, a diabetes drug, can lower overactive nerve signals in CKD patients which might reduce their cardiovascular risks. Patients will be randomly assigned to receive either Pioglitazone or a placebo for comparison.See study design
What are the potential side effects?
Pioglitazone may cause fluid retention leading to swelling and weight gain; it could also increase the risk of bone fractures especially in women and may lead to low blood sugar levels if taken with other diabetes medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately to severely reduced.
Select...
I am between 35 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Muscle sympathetic nerve activity (MSNA) will be reduced after 1 month of treatment with pioglitazone
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: PioglitazoneActive Control1 Intervention
The subjects will be given 1 month supply of Pioglitazone pills. Pioglitazone is a class of anti-diabetic drugs called thiazolidinediones that are primarily used in the treatment of type 2 diabetes. The aim of the study is to determine if Pioglitazone also reduces ADMA and sympathetic nerve activity in CKD patients. This drug will be taken orally as a pill or capsule for one month. The dosage is 15 mg/day. This is on the lower dosage side for pioglitazone with the maximum dosage being 45mg/day. The research subjects are not responsible for the cost of the drug or for drug administration costs. The subjects will be verbally instructed to take 1 pill everyday by mouth, for 1 month. In addition, the pill bottle will be labeled with the same instructions.
Group II: PlaceboPlacebo Group1 Intervention
Placebo pills are made of avicel microcrystalline cellulose and magnesium stearate, which are inactive ingredients in the Pioglitazone pills. The placebo pills will be of similar color and appearance as the Pioglitazone pills
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Who is running the clinical trial?
The University of Texas at ArlingtonLead Sponsor
43 Previous Clinical Trials
4,910 Total Patients Enrolled
University of Texas, Southwestern Medical Center at DallasOTHER
15 Previous Clinical Trials
21,443 Total Patients Enrolled
Paul J Fadel, PhDPrincipal InvestigatorUniversity of Texas at Arlington
3 Previous Clinical Trials
31 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure.I have had kidney stones in the past.I am not taking Dilantin or oral contraceptives due to their interaction with glitazones.My kidney function is moderately to severely reduced.I am HIV positive.I have had a heart attack.You are allergic to glitazones.I experience chest pain due to heart issues.You have experienced low blood sugar in the past.I am between 35 and 70 years old.I have had an organ transplant.I have liver disease.You are currently smoking or using tobacco products.I am currently on immunosuppressant therapy.I am currently receiving treatment for my cancer.You have very low levels of hemoglobin in your blood (less than 8 grams per deciliter).
Research Study Groups:
This trial has the following groups:- Group 1: Pioglitazone
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what therapeutic capacities is Pioglitazone usually administered?
"Pioglitazone is an approved therapeutic option for diabetes, as well as diabetic neuralgia and other conditions that may benefit from dietary or physical activity interventions."
Answered by AI
Are participants aged 20 and over accepted into the trial?
"This investigation is seeking volunteers over the age of 35 and below 70 years old."
Answered by AI
Has the Food and Drug Administration sanctioned Pioglitazone for public use?
"Due to the fact that Pioglitazone is a Phase 4 trial, meaning it has been approved by regulatory bodies, our team at Power determined its safety rating to be 3."
Answered by AI
How many individuals have opted to join this experiment?
"Affirmative. Clinicaltrials.gov documents verify that this clinical trial is actively recruiting participants, having been first posted on April 1st 2018 and most recently revised on May 24th 2022. 28 patients are needed from 2 distinct medical centres."
Answered by AI
Would I be eligible to partake in this research?
"This clinical trial has 28 openings for patients who have a diagnosis of kidney diseases and are between the ages 35 to 70."
Answered by AI
Are there any other research projects that have focused on Pioglitazone?
"At present, there are 31 studies concerning Pioglitazone with 4 in the third phase. While a bulk of these tests occur at Lausanne, Vaud, 69 venues worldwide are currently running trials for this drug."
Answered by AI
Are there any vacancies left for this research experiment?
"Yes, current records on clinicaltrials.gov show that this medical trial is in progress and recruiting patients. It was first published on April 1st 2018 with the latest update being made on May 24th 2022. This research project needs 28 participants from 2 different sites to complete their study."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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