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

NCT ID: NCT06786260

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

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.

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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional Diet

Subjects will follow a specified diet (low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake) after 1 week of preconditioning for 12 months.

Group Type: EXPERIMENTAL

Interventional Diet

Intervention Type: OTHER

Low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet

Regular Diet

Subjects will follow the diet they normally adhere to after 1 week of preconditioning.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interventional Diet

Low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amir Abdipour, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Locations

Loma Linda University Health

Loma Linda, California, United States

Countries

United States

Central Contacts

Niloufar Ebrahimi Ebrahimi, MD

Role: CONTACT

Nebrahimi@llu.edu

909-558-4000 ext. 55885

Sayna Norouzi, MD

Role: CONTACT

Snorouzi@llu.edu

909-558-4000

Facility Contacts

Amir Abdipour, MD

Role: primary

909-202-0252

Other Identifiers

5240615

Identifier Type: -

Identifier Source: org_study_id