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

NCT06786260 | Not Yet Recruiting

• 1 other identifier: 5240615
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

ADPKD; Diet

Outcome Measures

Primary Outcomes (1)

• Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months

  A composite measurement of MRI to determine total kidney volume (TKV) by kidney length, width, and depth will be done at baseline and again at 12 months. MRI results will be compared between the two-time points to assess the cyst progression, if any. An increase of about 5% per year from baseline will be significant.

  Change between baseline and 12 months

Secondary Outcomes (2)

• Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 12 months

  Change between baseline and 12 months

• Progression of kidney cysts as evidenced by serum biomarkers from baseline to 12 months

  Change between baseline and 12 months

Study Arms (2)

Interventional Diet

EXPERIMENTAL

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.

Other: Interventional Diet

Regular Diet

NO INTERVENTION

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

Interventions

Interventional Diet OTHER

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

Interventional Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Amir Abdipour, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niloufar Ebrahimi Ebrahimi, MD

CONTACT

909-558-4000; Nebrahimi@llu.edu

Sayna Norouzi, MD

CONTACT

909-558-4000; Snorouzi@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)