Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease

Overview

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. 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:

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Vicente Torres, M.D., Ph.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

More information

Publications

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