NCT03471117 Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
| NCT ID | NCT03471117 |
| Status | Terminated |
| Phase | Phase 4 |
| Sponsor | The University of Texas at Arlington |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2020-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 5 participants in total. It began in 2018-04-01 with a primary completion date of 2020-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Paul J Fadel, PhD
PRINCIPAL INVESTIGATOR
University of Texas at Arlington
Frequently Asked Questions
Who can join the NCT03471117 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 70 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03471117 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03471117 currently recruiting?
NCT03471117 is currently listed as "Terminated" and is not actively enrolling. Check ClinicalTrials.gov for the latest status updates.
Where is the NCT03471117 trial being conducted?
This trial is being conducted at Arlington, United States, Dallas, United States.
Who is sponsoring the NCT03471117 clinical trial?
NCT03471117 is sponsored by The University of Texas at Arlington. The principal investigator is Paul J Fadel, PhD at University of Texas at Arlington. The trial plans to enroll 5 participants.
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