NOX4 and Related Biomarkers in ADPKD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2027-01-31

Brief Summary

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To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).

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Detailed Description

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This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR\>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with a previous diagnosis of ADPKD

Patients that have been diagnosed with ADPKD and are classified as Class 1A, 1B, 1C, 1D and 1E.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ADPKD (based on Ravine et al. criteria)
* Class 1 A-E according to imaging classification
* Male and female subjects 15 - 40 years of age
* Estimated GFR\> 70 mL/min/1.73 m2 (CKD-EPI)
* Ability to provide written, informed consent

Exclusion Criteria

* Class 2 according to imaging classification
* Concomitant systemic disease affecting the kidney
* Diabetes mellitus
* Predicted urine protein excretion in \>1 g/24 hrs
* Use of antioxidants i.e. vitamins, Nrf2 activators
* Abnormal urinalysis

Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No