Autosomal Dominant Polycystic KidneyNCT03102632
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
A study testing High Water Intake in people with Autosomal Dominant Polycystic Kidney, run by The Rogosin Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney
- What is being tested?
- High Water Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
- estimated glomerular filtration rate of 40 ml/min or greater
- urine osmolality > 400 mOsm/L
Who cannot join
- estimated glomerular filtration rate less than 40 ml/min
- low blood sodium levels
- syndrome of inappropriate diuretic hormone
- use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
- use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP
- contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Autosomal Dominant Polycystic Kidney
- Being tested
- High Water Intake
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Water IntakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Water Intake | No intervention | For the first 6 months of the study, the participants will continue their usual water intake. |
| High Water Intake | Experimental | After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year. Receives: Other: High Water Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
Kidney function change
Blood creatinine levels will be measured and compared before and after the high water intake period.
Measured: 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.
Measured: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rogosin Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Martin Prince, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102632
- Sponsor's protocol ID
- 1701017921
- Status last verified
- Oct 2023
- First submitted
- 27 Mar 2017
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dev H, Zhu C, Barash I, Blumenfeld JD, He X, RoyChoudhury A, Wu A, Prince MR. Feasibility of Water Therapy for Slowing Autosomal Dominant Polycystic Kidney Disease Progression. Kidney360. 2024 May 1;5(5):698-706. doi: 10.34067/KID.0000000000000428. Epub 2024 Apr 1.
PubMed 38556640
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT03102632
- Acronym / sponsor ID
- 1701017921
- Conditions
- Autosomal Dominant Polycystic Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Rogosin InstituteUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.
| Arm | Type | Receives |
|---|---|---|
| Usual Water Intake | No intervention | –For the first 6 months of the study, the participants will continue their usual water intake. |
| High Water Intake | Experimental | Other: High Water IntakeAfter a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
- estimated glomerular filtration rate of 40 ml/min or greater
- urine osmolality > 400 mOsm/L
Key exclusion criteria (6 listed)
- estimated glomerular filtration rate less than 40 ml/min
- low blood sodium levels
- syndrome of inappropriate diuretic hormone
- use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
- use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Water IntakeAfter 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. | Other | High Water Intake |
Primary outcome
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.
2 secondary outcomes
Kidney function change
Time frame: 18 months
Change in urine and blood markers of response to high water intake
Time frame: 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 38556640Dev H, Zhu C, Barash I, Blumenfeld JD, He X, RoyChoudhury A, Wu A, Prince MR. Feasibility of Water Therapy for Slowing Autosomal Dominant Polycystic Kidney Disease Progression. Kidney360. 2024 May 1;5(5):698-706. doi: 10.34067/KID.0000000000000428. Epub 2024 Apr 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Prince, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Water Intake in people with Autosomal Dominant Polycystic Kidney, run by The Rogosin Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total kidney volume, as measured from magnetic resonance imaging (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.