Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

High Water Intake to Slow Progression of Polycystic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00784030
First received: October 31, 2008
Last updated: March 7, 2016
Last verified: March 2016
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Kidney, Polycystic, Autosomal Dominant
Intervention: Other: Water

  Participant Flow
  Hide 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
  Description
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 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide 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
  Description
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 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   10   23 
>=65 years   0   0   0 
Gender 
[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
  Hide 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
  Hide 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
e-mail: irina.barash@nyumc.org



Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00784030     History of Changes
Other Study ID Numbers: 08-774
Study First Received: October 31, 2008
Results First Received: April 25, 2012
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board