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Could a common diabetes drug protect the hearts of kidney patients?

NCT ID NCT03471117

Disease control Sponsor: The University of Texas at Arlington Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

People with chronic kidney disease (CKD) often have an overactive sympathetic nervous system, which raises their risk of heart problems and death. This phase 4 trial tests whether pioglitazone, a drug usually used for diabetes, can reduce that nerve overactivity and improve blood vessel function. The study enrolls adults aged 35 to 70 with moderate-to-severe CKD (stages 3 and 4). Participants receive either pioglitazone or a placebo daily for one month, and researchers measure nerve activity directly using a tiny electrode inserted near the knee.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pioglitazone, a drug typically used for diabetes
What this could lead to
If it works, pioglitazone could offer a new way to lower cardiovascular risk in people with chronic kidney disease by calming an overactive nervous system.
What could go wrong
This is a very small, early-phase trial with only 5 participants, so results may not apply broadly. Pioglitazone also carries known risks, including fluid retention and potential liver effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

5 people

The number who actually took part.

Started

Apr 2018

Finished

Jan 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Allergy to Glitazones * Myocardial infarction * Heart failure * Angina * History of kidney stones * Liver disease (abnormal liver enzymes) * Anemia (hemoglobin \<8 g/dl) * Cancer with current treatment * Previous organ transplantation * Immunosuppressant therapy * Human immunodeficiency virus infection * Pregnancy or lactating * Current tobacco use * Dilantin and oral contraceptive usage due to potential drug interaction with glitazones * Self-identified history of hypoglycemia

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases

Contacts and locations

Locations

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University of Texas at Arlington

    Arlington, Texas, 76010, United States

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