NCT00784030

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

April 6, 2016

Completed
Last Updated

April 6, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

October 31, 2008

Results QC Date

April 25, 2012

Last Update Submit

March 7, 2016

Conditions

Kidney, Polycystic, Autosomal Dominant

Keywords

Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseaseWater LoadingBiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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

    pre- and post-water loading (2 hours)

Study Arms (2)

Polycystic Kidney Disease Patients

OTHER

Patients who present with polycystic kidney disease (PKD)

Other: Water

Healthy Patients

OTHER
Other: Water

Interventions

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.

Healthy PatientsPolycystic Kidney Disease Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantPolycystic Kidney Diseases

Interventions

Water

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Irina Barash
Organization
New York University School of Medicine
irina.barash@nyumc.org
212.263.5851

Study Officials

  • Irina Barash, M.D.

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

November 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 6, 2016

Results First Posted

April 6, 2016

Record last verified: 2016-03

Locations

US(1)