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

Loma Linda University (LLU)

Status: Begins enrollment in 2 months

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Treatments: Other: Interventional Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06786260

5240615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Interventional Diet

Experimental group

Description:

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.

Treatment:

Other: Interventional Diet

Regular Diet

No Intervention group

Description:

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