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

NCT04344769 | Recruiting

• 2 other identifiers: 17-008806R21DK118391
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Oxidative Stress; Antioxidant Response; Nrf2; ADPKD

Outcome Measures

Primary Outcomes (3)

• Assessment of Oxidative Status

  Determination of common biomarkers of oxidative damage including but not limited to: 8-oxodeoxyguanosine, F2-isoprostanes, from urine and plasma samples

  Baseline

• Assessment of Antioxidant Response

  Determination of antioxidants including but not limited to: Heme Oxygenase 1 (HO-1), Superoxide dismutase (SOD), catalase, glutathione reductase (GSR), glutathione peroxidase (GPx), and NAD(P)H dehydrogenase \[quinone\] 1 (NOQ1), glutathione, Nrf2 from urine and plasma samples

  Baseline

• Total kidney volume (TKV)

  Determined by MRI

  Baseline

Secondary Outcomes (1)

• Assessment of Kidney Injury

  Baseline

Study Arms (2)

Patients with a previous diagnosis of ADPKD

Patients that have been diagnosed with ADPKD and meet the study's inclusion criteria

Healthy individuals as controls

Age and gender-matched healthy controls

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Male and female patients with a previous diagnosis of ADPKD that meet the inclusion criteria. In addition, patients will be matched 1:1 to age and gender healthy volunteers.

You may qualify if:

• ADPKD (based on Ravine et al. criteria)
• Class 1 B-E according to our imaging classification
• Male and female subjects 18 - 30 years of age, inclusive
• Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
• Ability to provide written, informed consent.

You may not qualify if:

• Class 2 according to our imaging classification
• Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
• Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
• Predicted urine protein excretion in urinalysis \>1 g/24 hrs
• Abnormal urinalysis suggestive of concomitant glomerular disease.
• Subjects having contraindications to, or interference with MRI assessments. \[For example: ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc\].
• Female subjects that are pregnant
• Male and female subjects 18 - 30 years of age, inclusive
• Estimated GFR\> 60 mL/min/m2 (CKD-EPI equation)
• Ability to provide written, informed consent.
• Previous personal or family history of kidney disease.
• Concomitant systemic disease in the kidney (e.g. lupus, hepatitis B or C, amyloidosis)
• Diabetes mellitus (fasting glucose \> 126 mg/dL or treatment with insulin or oral hypoglycemics).
• Presence of proteinuria
• Abnormal urinalysis suggestive glomerular disease.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and plasma samples

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Maria V. Irazabal, M.D., Ph.D

  Mayo Translational PKD Center, Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelfattah

CONTACT

Abdelfattah.Ahmed@mayo.edu

Maria V Irazabal, M.D., Ph.D

CONTACT

507-884-5628; irazabalmira.maria@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: October 4, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)