Understanding oxidative stress in patients with Autosomal Dominant Polycystic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize oxidative stress and the Nrf2 antioxidant response in early stages of Autosomal Dominant Polycystic Kidney Disease (ADPKD). It focuses on measuring intracellular Reactive Oxygen Species (ROS) levels and identifying candidate biomarkers that could lead to more effective therapies. By examining the balance between oxidative stress and antioxidant responses, the study seeks to enhance understanding of disease progression and potential treatment pathways. Participants will include young adults diagnosed with ADPKD, and the study will utilize advanced imaging techniques to gather data.

Why it matters

Who can join: the full rules

Inclusion Criteria (ADPKD Subjects):

* 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.

Exclusion Criteria (ADPKD Subjects):

* 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

Inclusion Criteria (Healthy Subjects):

* 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.

Exclusion Criteria (Healthy Subjects):

* 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.
* 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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Maria V. Irazabal, M.D., Ph.D — Mayo Translational PKD Center, Mayo Clinic
• Study coordinator: Ahmed Abdelfattah
• Email: Abdelfattah.Ahmed@mayo.edu

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing Depressive Symptoms in ADPKD: testing Digital Neurotherapy and Capacity Coaching

  This study tests whether Digital Neurotherapy or Capacity Coaching can help people with ADPKD who have depression and self-reported pain, compared to education alone.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07745920

• AZD1613 safety and how the body handles it in adults with ADPKD

  We will test whether AZD1613 given under the skin or into a vein is safe and how the body processes it in adults with ADPKD who have eGFR between 45 and 90 mL/min/1.73m2.

  Recruiting at 10 sites Phase 1 AstraZeneca · Birmingham, Alabama and 14 other locations · NCT07228364

• Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

  This trial will test whether intravenous ABBV-CLS-628 given every 4 weeks is safe and helps adults with ADPKD.

  Recruiting at 72 sites Phase 2 Calico Life Sciences LLC · Birmingham, Alabama and 90 other locations · NCT06902558

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

• Using Metformin to Slow Kidney Decline in Polycystic Kidney Disease

  This study is testing if metformin can help slow down kidney problems in adults with early-stage Polycystic Kidney Disease.

  Recruiting at 24 sites Phase 3 The University of Queensland · Gosford, New South Wales and 48 other locations · NCT04939935

• Evaluating biomarkers in early autosomal dominant polycystic kidney disease

  This study is trying to see if certain biomarkers can help understand how severe early autosomal dominant polycystic kidney disease is for young patients aged 15 to 40.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04630613

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.