Active — Not RecruitingNot Applicable

A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD

United States80 participantsStarted 2021-09-14

Plain-language summary

The purpose of this study is to assess homocysteine metabolism and systemic endothelial function at the early stages of the disease and determine the prognostic value of homocysteine, related metabolites, and markers of endothelial function and injury to estimate renal disease severity and progression in patients with early Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Who can participate

Age range15 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and Female subjects, 15-40 years of age, inclusive * Previous diagnosis of ADPKD (Based on Ravine et al. criteria) * Class 1 according to imaging classification * Estimated GFR\>70 mL/min/1.73m\^2(CKD-EPI) * Ability to provide written, informed consent. Exclusion Criteria: * Class 2 according to imaging classification * A concomitant systemic disease affecting the kidney * Diabetes mellitus * Predicted urine protein excretion in urinalysis \>1 g/24 hrs * Subjects having contraindications to or interference with MRI assessments * Patients that are part of an interventional study or taking tolvaptan * Female subjects that are pregnant

What they're measuring

Change in height adjusted Total kidney volume (htTKV)

Timeframe: Baseline to 24 months

Baseline endothelial function, homocysteine and related metabolite levels as predictors of change in TKV

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT05193981

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney Disease trials