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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

Must not have

Heart failure

History of kidney stones

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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 below

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My kidney function is moderately to severely reduced.

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I am between 35 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart failure.

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I have had kidney stones in the past.

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I am HIV positive.

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I have had a heart attack.

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I experience chest pain due to heart issues.

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I have had an organ transplant.

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I have liver disease.

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I am currently on immunosuppressant therapy.

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I am currently receiving treatment for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle sympathetic nerve activity (MSNA) will be reduced after 1 month of treatment with pioglitazone

Awards & Highlights

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.

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

0 / 11Eligibility criteria met