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NCT Number: NCT06786260

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

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location contact

Amir Abdipour, MD

CONTACT

909-202-0252

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interventional Diet

Other

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

Primary outcomes

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

    Time frame: Change between baseline and 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.

Secondary outcomes

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

    Time frame: Change between baseline and 12 months

    A urine sample will be collected at the end of the preconditioning week to establish a baseline for the urinary biomarkers cAMP and MCP-1. This is a composite measurement. Values for cAMP and MCP-1 at 12 months will be compared to the baseline values. If the values at 12 months remain the same or less than the composite baseline values, this will indicate a low likelihood that the kidney cysts have progressed. A significant change of 20% or greater overall in the combined biomarkers will indicate a kidney cyst progression.

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

    Time frame: Change between baseline and 12 months

    A blood draw will be performed at the end of the preconditioning week to establish a baseline for the serum biomarkers uric acid, ADH, FGF-23, bicarbonate, and cystatin C. This is a composite measurement. Values for uric acid, ADH, FGF-23, bicarbonate, and cystatin C at 12 months will be compared to the baseline values. If the values at 12 months remain the same or less than the composite baseline values, this will indicate a low likelihood that the kidney cysts have progressed. A significant change of 20% or greater overall in the combined biomarkers will indicate a kidney cyst progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Niloufar Ebrahimi Ebrahimi, MD

CONTACT

[email protected]

909-558-4000 ext. 55885

Sayna Norouzi, MD

CONTACT

[email protected]

909-558-4000

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Acronym: ADPKD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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