Kidney, Polycystic, Autosomal DominantNCT00784030

High Water Intake to Slow Progression of Polycystic Kidney Disease

A study testing Water in people with Kidney, Polycystic, Autosomal Dominant, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Kidney, Polycystic, Autosomal Dominant
What is being tested?: Water
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Nov 2008to May 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
Ages between 18 and 65
Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) > 60 ml/min/1.73 m2 with no history of kidney disease

Who cannot join

Women who are pregnant or nursing
Active dependency on drugs or alcohol
Diagnosis of syndrome of inappropriate antidiuresis
Currently taking a vasopressin agonist or antagonist
Blood sodium level less than < 135 mEq/L
For healthy participants, estimated glomerular filtration rate (level of kidney function) less than < 60 ml/min/1.73 m2

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University Langone Medical Center
New York, New York, 10016

Other trials in United States

About this study

Official title: The Effect of Water Loading on Urinary Biomarkers

Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.

Conditions: Kidney, Polycystic, Autosomal Dominant
Being tested: Water
Keywords: Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, Water Loading, Biomarkers
Medical subject headings: Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WaterOther
Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.

Study groups in NCT00784030
Study group	Role	What they receive
Polycystic Kidney Disease Patients	Other	Patients who present with polycystic kidney disease (PKD) Receives: Other: Water
Healthy Patients	Other	Not described Receives: Other: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours
Measured: pre- and post-water loading (2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008May 2009

First posted3 Nov 2008 (estimated)
Study startNov 2008
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney, Polycystic, Autosomal DominantStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784030
Sponsor's protocol ID: 08-774
Status last verified: Mar 2016
First submitted: 31 Oct 2008
Last updated: 6 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Kidney, Polycystic, Autosomal Dominant trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Water Loading on Urinary Biomarkers
ClinicalTrials.gov ID: NCT00784030
Acronym / sponsor ID: 08-774
Conditions: Kidney, Polycystic, Autosomal Dominant
Keywords: Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, Water Loading, Biomarkers
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: Nov 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 3 Nov 2008 (estimated)
Results: Posted 6 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Polycystic Kidney Disease Patients	Other	Other: WaterPatients who present with polycystic kidney disease (PKD)
Healthy Patients	Other	Other: Water

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
Ages between 18 and 65
Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) > 60 ml/min/1.73 m2 with no history of kidney disease

Key exclusion criteria (6 listed)

Women who are pregnant or nursing
Active dependency on drugs or alcohol
Diagnosis of syndrome of inappropriate antidiuresis
Currently taking a vasopressin agonist or antagonist
Blood sodium level less than < 135 mEq/L

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
WaterParticipants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.	Other	Healthy Patients, Polycystic Kidney Disease Patients

Primary outcome

Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
Time frame: pre- and post-water loading (2 hours)
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours

Results and safety

Results posted to the registry on 6 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Polycystic Kidney Disease (PKD) Patients	13	13
Healthy Patients	10	10

Primary outcome: Change in Urine cAMP Concentration and Urine Osmolality (UOsm)

Time frame: pre- and post-water loading (2 hours). Mean (Standard Error). Unit: fold change in cAMP/UOsm (umol/UOsm)

Measure	Polycystic Kidney Disease Patients n = 13	Healthy Controls n = 10
Value	-2.6 (0.2)	-2.0 (0.1)

Population analysed: Number of participants was deemed to be adequate for the purposes of this pilot study

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Polycystic Kidney Disease Patients	0 of 13 (0%)	0 of 13 (0%)	Not reported
Healthy Controls	0 of 10 (0%)	0 of 10 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a very small study, so larger numbers are needed. Urine cAMP measurement as a surrogate of response to water treatment needs further validation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney, Polycystic, Autosomal Dominant

RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

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.

Irina Barash, M.D. principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Water in people with Kidney, Polycystic, Autosomal Dominant, run by NYU Langone Health 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 4 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 6 Apr 2016. 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?

Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Urine cAMP Concentration and Urine Osmolality (UOsm) (time frame: pre- and post-water loading (2 hours)). 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 NCT00784030.

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 6 Apr 2016.