A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03102632|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : July 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Autosomal Dominant Polycystic Kidney||Other: High Water Intake||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The radiologist measuring kidney volumes will be masked to the study condition.|
|Official Title:||A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||April 2020|
No Intervention: Usual Water Intake
For the first 6 months of the study, the participants will continue their usual water intake.
Experimental: High 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 [ Time Frame: 18 months ]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.
- Kidney function change [ Time Frame: 18 months ]Blood creatinine levels will be measured and compared before and after the high water intake period.
- Change in urine and blood markers of response to high water intake [ Time Frame: 18 months. ]Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102632
|Contact: Ines G Chicosemail@example.com|
|Contact: Irina Barash, MD, MSfirstname.lastname@example.org|
|United States, New York|
|The Rogosin Institute||Recruiting|
|New York, New York, United States, 10021|
|Contact: Ines G Chicos 212-746-3541 email@example.com|
|Contact: Irina Barash, MD, MS 212-746-9077 firstname.lastname@example.org|
|Principal Investigator:||Irina Barash, MD, MS||The Rogosin Institute|