28 Participants Needed

Pioglitazone for Chronic Kidney Disease

Recruiting at 1 trial location
PJ
Overseen ByPaul J Fadel, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas at Arlington
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using Dilantin or oral contraceptives due to potential drug interactions with the study drug, pioglitazone.

What data supports the effectiveness of the drug Pioglitazone for chronic kidney disease?

Research suggests that Pioglitazone, a drug that helps improve insulin sensitivity, may also protect the kidneys by reducing inflammation and oxidative stress (damage caused by free radicals) in animal models. Additionally, it has shown benefits in managing diabetes, which is often linked to kidney problems.12345

Is pioglitazone safe for humans?

Pioglitazone has been studied in over 5,400 people and is generally considered safe, though it can cause weight gain and fluid retention. It has been used by over 1.4 million patients, and no serious adverse effects have been commonly reported.36789

How is the drug pioglitazone unique for treating chronic kidney disease?

Pioglitazone is unique because it works by activating a specific protein in the body that helps reduce kidney damage and improve kidney function, especially in conditions like diabetes. Unlike some other treatments, it enhances the body's antioxidative capacity and reduces harmful blood vessel growth in the kidneys.12101112

What is the purpose of this trial?

Chronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. Recently, some studies have shown that a drug typically used to improve glucose control (pioglitazone) may also reduce sympathetic nerve activity and improve blood vessel function.The goal of this study is to determine whether a short-term treatment with pioglitazone can reduce sympathetic nerve impulses throughout the body in CKD patients.

Research Team

PJ

Paul J Fadel, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

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.

Inclusion Criteria

My kidney function is moderately to severely reduced.
I am between 35 and 70 years old.

Exclusion 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.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pioglitazone or placebo for 1 month to assess reduction in ADMA and sympathetic nerve activity

1 month
1 visit (in-person) for drug dispensation and instructions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person) for follow-up assessments

Treatment Details

Interventions

  • Pioglitazone
  • Placebo
Trial Overview 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.
Participant Groups
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

Pioglitazone is already approved in United States for the following indications:

🇺🇸
Approved in United States as Actos for:
  • Type 2 diabetes mellitus

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials
48
Recruited
7,300+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials
18
Recruited
21,200+

Findings from Research

In a study involving 27 participants with varying degrees of renal function, pioglitazone was found to be well tolerated across all groups, indicating its safety in patients with renal impairment.
While patients with severe renal impairment showed increased serum concentrations of pioglitazone and its metabolites, the pharmacokinetic profiles were not significantly different from those with normal or moderate renal function, suggesting that dose adjustments may not be necessary.
The pharmacokinetics of pioglitazone in patients with impaired renal function.Budde, K., Neumayer, HH., Fritsche, L., et al.[2019]
In a rat model of chronic kidney disease, pioglitazone significantly improved kidney structure and function, as shown by reduced levels of harmful substances like blood urea nitrogen and creatinine.
Pioglitazone enhanced the kidney's antioxidative capacity and inhibited harmful angiogenesis by down-regulating key angiogenic factors, suggesting it could be a promising treatment for chronic kidney diseases.
Pioglitazone, a Peroxisome Proliferator-Activated Receptor x03B3; Agonist, Ameliorates Chronic Kidney Disease by Enhancing Antioxidative Capacity and Attenuating Angiogenesis in the Kidney of a 5/6 Nephrectomized Rat Model.Sun, L., Yuan, Q., Xu, T., et al.[2019]
Pioglitazone effectively increases insulin sensitivity and improves glycemic control in patients with type 2 diabetes, whether used alone or in combination with other medications, based on clinical trials.
The medication is generally well tolerated, with weight gain and edema being the most common side effects, and it also shows potential benefits in reducing cardiovascular risk and arteriosclerosis.
Spotlight on pioglitazone in type 2 diabetes mellitus.Waugh, J., Keating, GM., Plosker, GL., et al.[2019]

References

The pharmacokinetics of pioglitazone in patients with impaired renal function. [2019]
Pioglitazone, a Peroxisome Proliferator-Activated Receptor x03B3; Agonist, Ameliorates Chronic Kidney Disease by Enhancing Antioxidative Capacity and Attenuating Angiogenesis in the Kidney of a 5/6 Nephrectomized Rat Model. [2019]
Spotlight on pioglitazone in type 2 diabetes mellitus. [2019]
Pioglitazone limits cyclosporine nephrotoxicity in rats. [2022]
Beraprost Sodium Delays the Decline of Glomerular Filtration Rate in Patients with Diabetic Nephropathy: A Retrospective Study. [2023]
Comparative effectiveness research using electronic health records: impacts of oral antidiabetic drugs on the development of chronic kidney disease. [2022]
Safety and efficacy of low dose pioglitazone compared with standard dose pioglitazone in type 2 diabetes with chronic kidney disease: A randomized controlled trial. [2022]
Safety profile of pioglitazone. [2022]
Use of Potentially Nephrotoxic Medications by U.S. Adults with Chronic Kidney Disease: NHANES, 2011-2016. [2021]
Comparison of the Effects of Pioglitazone versus Placebo when Given in Addition to Standard Insulin Treatment in Patients with Type 2 Diabetes Mellitus Requiring Hemodialysis: Results from the PIOren Study. [2022]
Protective effect of pioglitazone on kidney injury in diabetic rats. [2018]
Effect of pioglitazone on diabetic nephropathy and expression of HIF-1α and VEGF in the renal tissues of type 2 diabetic rats. [2018]
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