Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-009797
    Sponsor Protocol Number: 16-009797

About this study

The purpose of this study is to conduct a controlled, unblinded RCT comparing mild CR to a control diet in patients with rapidly progressive ADPKD (class 1C-E by the lrazabal classification), under conditions of standardized hydration and sodium intake, to determine whether it slows the rate of growth of the kidneys (primary endpoint), is well tolerated and safe, lowers levels of IGF-1 in serum and the excretion of inflammation (MCP-1) and fibrosis (TGF-􀁇) biomarkers in urine, improves kidney texture, slows the decline of GFR and the rate of growth of the liver, and improves the quality of life.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Males and Females ages 18-45
  • Diagnosis of ADPKD with rapid progression as defined by class 1C to 1D by the imaging classification of Irazabal et al
  • eGFR (CD-Epi) >60mL/min/1.73m² within 6 weeks of randomization and adjusted BMI ≥22 kg/m² and ≤34 kg/m²

Exclusion Criteria:

  • History of eating disorders such as anorexia bulimia
  • Women pregnant, breast feeding or of childbearing potential not agreeing to practice birth control during the trial
  • Contraindication to or interference with MRI assessments
  • History of non-compliance with medical therapy or of substance abuse within the previous 2 years
  • Conditions or treatments confounding endpoint assessments (e.g. diabetes mellitus, other CKD, renal cancer, single kidney)
  • Participation in other clinical trials to slow ADPKD or CKD

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vicente Torres, M.D., Ph.D.

Contact us for the latest status

Contact information:

Lisa Bungum CCRP

(507)266-4616

Bungum.Lisa2@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20313160

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