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NCT06786260 | NOT YET RECRUITING | Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:

Loma Linda University

Brief Summary:

The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD). Researchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.

Condition or disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Intervention/treatment

Interventional Diet

Phase

NA

Detailed Description:

15 subjects will be enrolled in each dietary arm for a total of 30 subjects. All subjects will follow the study diet for one week, after which serum and urinary biomarkers will be measured. A baseline evaluation, including genetic testing, MRI, Mayo Clinic Imaging Classification and 10-question survey will also be conducted. After Week 1 of the study, subjects will be assigned to the intervention or control arm. Subjects will have six follow-up visits at months 1, 2, 3, 6, 9 and 12 to assess adherence to diet. Serum and urinary biomarkers will be repeated at each visit. MRI will be repeated at Month 12.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date : 2025-07
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Confirmed diagnosis of ADPKD
  • * Genetic testing confirmation of PKD1 or PKD2
  • * eGFR \>30mL/1.73m2
  • * Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study
  • * Mayo Clinic Imaging Classification (MCIC): 1C, 1D, 1E
Exclusion Criteria
  • * History of dietary non-adherence
  • * Subjects on Tolvaptan
  • * Comorbidities that could interfere with participation (Diabetes, Heart Failure (EF\<30%) Advanced Chronic Kidney Disease (CKD) Stage 4 and higher)
Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease

Location Details

NCT06786260

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Loma Linda University Health

Loma Linda, California, United States, 92354