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

ConditionAutosomal Dominant Polycystic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-30
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: Patients with a previous diagnosis of ADPKD
Group B: Healthy individuals as controls

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline
2

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

Time frame
Baseline
3

Total kidney volume (TKV)

Determined by MRI

Time frame
Baseline

Secondary outcomes

1

Assessment of Kidney Injury

Determination of kidney injury biomarkers including but not limited to: Kidney Injury Molecule 1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), Monocyte chemotactic protein-1 (MCP-1), Transforming growth factor-β1 (TGF-β1),

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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