Using pioglitazone to lower nerve activity in chronic kidney disease patients
Targeting ADMA With Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
PHASE4 · The University of Texas at Arlington · NCT03471117
This study is testing if the diabetes drug pioglitazone can help reduce nerve activity and improve heart health in people with chronic kidney disease.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | The University of Texas at Arlington (other) |
| Locations | 2 sites (Arlington, Texas and 1 other locations) |
| Trial ID | NCT03471117 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of pioglitazone, a medication typically used for diabetes, on reducing sympathetic nerve activity in patients with chronic kidney disease (CKD). The research focuses on CKD patients classified as Stage 3 and 4, aiming to determine if short-term treatment with pioglitazone can improve cardiovascular outcomes by lowering sympathetic nerve impulses. The study will compare the effects of pioglitazone against a placebo to assess its efficacy in this patient population. By targeting sympathetic overactivity, the study seeks to address a significant cardiovascular risk factor in CKD patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 70 with Stage 3 or 4 chronic kidney disease and specific glomerular filtration rates.
Not a fit: Patients with a history of heart disease, liver disease, or certain other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce cardiovascular risks and improve overall health outcomes for patients with chronic kidney disease.
How similar studies have performed: While the approach of using pioglitazone for this purpose is novel, previous studies have indicated potential benefits of targeting sympathetic overactivity in CKD patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arlington, Texas and 1 other locations
- University of Texas at Arlington — Arlington, Texas, United States (RECRUITING)
- UT Southwestern — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Paul J Fadel, PhD — University of Texas at Arlington
- Study coordinator: Paul J Fadel, PhD
- Email: Paul.Fadel@uta.edu
- Phone: 8172724653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, blood pressure, pioglitazone, hypertension