Role of ROS and cAMP-PKA Biomarkers in ADPKD

NCT07217158 | Active Not Recruiting

• 1 other identifier: 23-000116
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the prognostic value of markers of ROS and cAMP-PKA signaling to assess disease severity and progression in patients with ADPKD.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal Dominant Polycystic Kidney Disease (ADPKD); Oxidative stress; Antioxidant response; Mitochondria injury

Outcome Measures

Primary Outcomes (3)

• Change in height adjusted Total kidney volume (htTKV)

  TKV determined by MRI

  Baseline to 24 months

• Change in eGFR

  eGFR estimated by CKD-EPI

  Baseline to 24 months

• Baseline concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites as predictors of change in TKV and eGFR

  Biochemical markers determined by ELISA and/or biochemical assays, PCR, TKV determined by MRI, eGFR estimated by CKD-EPI.

  Baseline to 24 months

Secondary Outcomes (1)

• Change in concentration of: NOX4, biochemical markers related to ROS, mitochondrial injury and metabolites

  Baseline to 24 months

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with a previous diagnosis of ADPKD that meet the inclusion criteria.

You may qualify if:

• Male and female subjects 15 - 70 years of age
• Previous diagnosis of ADPKD (based on Ravine et al. criteria)
• Class 1 A-E according to imaging classification
• estimated GFR\> 45 mL/min/1.73 m2 (CKD-EPI)
• Ability to provide written, informed consent

You may not qualify if:

• Class 2, according to imaging classification
• A concomitant systemic disease affecting the kidney
• Diabetes mellitus
• Predicted urine protein excretion in \>1 g/24 hrs. and or abnormal urinalysis
• Use of antioxidants, i.e., vitamins, Nrf2 activators
• Patients who are part of an interventional study or taking tolvaptan

Sponsors & Collaborators

• Mayo Clinic: lead
• United States Department of Defense: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

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 Clinic

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: July 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)