An interventional study of High Water Intake in Autosomal Dominant Polycystic Kidney, sponsored by The Rogosin Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by The Rogosin Institute · Not applicable, Interventional, and Treatment
Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and effective long-term treatment regimen. Unfortunately, there are still no disease-specific treatment for ADPKD approved in the US. A rational step towards identifying such agents is to test therapies that have a proven safety profile with mechanisms of action that can counter the disease progression.
The purpose of this study is to investigate whether drinking increased amounts of water (water loading) might slow down polycystic kidney growth or kidney function decline. Water loading can cause the suppression of a pathway that causes fluid buildup and cyst growth. High water intake has been safely used in the clinical setting, such as in the case of kidney stone therapy. New York State tap water is widely available and safe, making it highly cost-effective as well.
The study will involve 11 visits to the study site over 19 months. Participants will need to follow specific dietary and fluid recommendations. There will be physical examinations and medical history assessments at each visit. Testing will include undergoing magnetic resonance imaging (MRI), blood and urine tests. Study participants will be compensated for their time. Detailed study procedures will be reviewed upon contact with the study team.
Exclusion Criteria:
For the first 6 months of the study, the participants will continue their usual water intake.
After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.
Other: High Water Intake
After 6 months of usual, unchanged diet and fluid intake, participants will be asked to increase the daily fluid intake based on the principal investigator's prescription. The actual amount of extra water prescribed will depend on the results of the participant's 24 hour urine test.
Change in total kidney volume, as measured from magnetic resonance imaging
Total kidney volumes will be measured before and after the period of high water intake. Kidney volume growth with high water intake will be compared to baseline kidney volume growth.
Time frame: 18 months
Kidney function change
Blood creatinine levels will be measured and compared before and after the high water intake period.
Time frame: 18 months
Change in urine and blood markers of response to high water intake
Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.
Time frame: 18 months.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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The Rogosin Institute