Other Clinical Trial - Characterization of the Nrf2 Response in Patients

Status Recruiting

Clinical Trial Summary

The purpose of this study is to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD), while identifying candidate biomarkers.

Clinical Trial Description

Intracellular Reactive Oxygen Species (ROS) concentration is a major determinant of cellular fate and is finely regulated by the cell's antioxidant systems. While low levels of ROS are required for pro-survival signaling, cell proliferation, growth, and energy metabolism, the excess of ROS or oxidative stress leads to inflammation, cell death, and disease/injury progression. Indeed, oxidative stress is commonly observed in several renal diseases including ADPKD. On the other hand, a surplus of antioxidants will not only neutralize ROS, but may result in the antithesis of oxidative stress, which is known as reductive stress. The Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) is a transcription factor that integrates cellular stress signals and responds by regulating the expression of several antioxidant proteins. Activation of the Nrf2-mediated antioxidant defense pathway enhances ROS detoxification, conferring a more reduced intracellular environment that can promote cell survival and proliferation, a distinctive feature in ADPKD that underlies cyst formation and enlargement. Therefore, a better characterization of ROS levels and antioxidant response in ADPKD patients would allow development of more specific and effective therapies, while providing additional related biomarkers. The investigators broad objective is to characterize oxidative stress and the Nrf2 antioxidant response in early stages of ADPKD, while identifying candidate biomarkers. Participants in this study will have a blood and a urine sample collected to determine biomarkers of oxidative status and antioxidant response to study redox balance at early stages of the disease. In addition, an abdominal MRI will be performed to determine patient's total kidney volume (TKV). ;

Study Design

Related Conditions & MeSH terms

Arthrogryposis
Autosomal Dominant Polycystic Kidney Disease
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant

Clinical Trial Details

NCT number	NCT04344769
Study type	Observational
Source	Mayo Clinic
Contact	Ahmed Abdelfattah
Email	Abdelfattah.Ahmed@mayo.edu
Status	Recruiting
Phase
Start date	October 4, 2019
Completion date	December 2024

View Details

See also
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Recruiting	`NCT05190744` - PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration	Phase 2
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Active, not recruiting	`NCT02848521` - A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
Completed	`NCT01451827` - 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)	Phase 2
Completed	`NCT01336972` - Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)	Phase 2
Completed	`NCT01210560` - Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD	Phase 2
Completed	`NCT02134899` - The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients	Phase 3
Active, not recruiting	`NCT02729662` - Efficacy of Tolvaptan on ADPKD Patients	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms