Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interventional Diet.
- Who it may be relevant to
- Registry conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease
Overview
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.
Interventions
- Other Interventional Diet
Low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet
Primary outcome measures
- Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months [Time frame: Change between baseline and 12 months]
Secondary outcome measures (2)
- Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 12 months [Time frame: Change between baseline and 12 months]
- Progression of kidney cysts as evidenced by serum biomarkers from baseline to 12 months [Time frame: Change between baseline and 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Loma Linda University Health — Loma Linda
Identifiers
NCT: NCT06786260 · 5240615