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Regulus Biomarker

Overview

About this study

The purpose of this study is to investigate the biological variation in baseline levels of proteins (uELV PC1 and PC2) in individual Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients within a 14 day period that will enable the further optimization of biomarker assays for measuring uELV PC1 and PC2.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
  • Age ≥ 18 to 65 years old.
  • Must have Class 1C, 1D or 1E Mayo Imaging Classification of ADPKD  (based upon an MRI obtained in the year prior to randomization).
  • Must have estimated GFR between 30 to 90 mL/min/1.73 m^2 from screening serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI).

Exclusion Criteria:

  • Administration of tolvaptan in the 30 days prior to sample collection.
  • Mayo Class 1A 1B ADPKD.
  • Unable to travel to Mayo Clinic.
  • Unable to provide consent.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Marie Hogan, M.D., Ph.D.

Open for enrollment

Contact information:

Kathleen Leistikow

(507) 266-1316

Leistikow.Kathleen@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20509063

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