High Water Intake to Slow Progression of Polycystic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784030
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Kidney, Polycystic, Autosomal Dominant
Intervention: Other: Water

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Polycystic Kidney Disease (PKD) Patients Patients who present with polycystic kidney disease (PKD)
Healthy Patients No text entered.

Participant Flow:   Overall Study
    Polycystic Kidney Disease (PKD) Patients   Healthy Patients
STARTED   13   10 
COMPLETED   13   10 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Polycystic Kidney Disease (PKD) Patients No text entered.
Healthy Patients No text entered.
Total Total of all reporting groups

Baseline Measures
   Polycystic Kidney Disease (PKD) Patients   Healthy Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   10   23 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   13   10   23 
>=65 years   0   0   0 
[Units: Participants]
Female   8   7   15 
Male   5   3   8 

  Outcome Measures

1.  Primary:   Change in Urine cAMP Concentration and Urine Osmolality (UOsm)   [ Time Frame: pre- and post-water loading (2 hours) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Irina Barash
Organization: New York University School of Medicine
phone: 212.263.5851

Responsible Party: New York University School of Medicine Identifier: NCT00784030     History of Changes
Other Study ID Numbers: 08-774
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: April 25, 2012
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016