Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Interventional Diet
Other interventionLow salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Interventional DietExperimental treatment 1 intervention
Group B: Regular DietNo intervention 0 interventions
Trial outcomes
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.
Time frame
Change between baseline and 12 monthsSecondary outcomes
1
Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 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.
Time frame
Change between baseline and 12 months2
Progression of kidney cysts as evidenced by serum biomarkers from baseline to 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.
Time frame
Change between baseline and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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