NCT06786260

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

Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

Type	Name	Description
OTHER	Interventional Diet	Low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-01-22
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States