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Trial record 47 of 108 for:    "polycystic kidney disease"

Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy

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ClinicalTrials.gov Identifier: NCT00920309
Recruitment Status : Terminated (This study was stopped after larger studies published in the NEJM failed to show a benefit in treating ADPKD)
First Posted : June 15, 2009
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Autosomal Dominant Polycystic Kidney Disease
Interventions: Drug: Rapamycin
Other: Standard of Care-Placebo

  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
Rapamycin

Drug: Rapamycin

Other Names:

sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml.

Standard of Care-Placebo No text entered.

Participant Flow:   Overall Study
    Rapamycin   Standard of Care-Placebo
STARTED   14   7 
COMPLETED   14   7 
NOT COMPLETED   0   0 



  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
Rapamycin

Drug: Rapamycin

Other Names:

sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml.

Standard of Care-Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Rapamycin   Standard of Care-Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   7   21 
Age 
[Units: Years]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   7   20 
>=65 years   1   0   1 
Gender 
[Units: Participants]
     
Female   5   2   7 
Male   9   5   14 


  Outcome Measures

1.  Primary:   Total Kidney Volume (mL)   [ Time Frame: 2 years ]

2.  Secondary:   Glomerular Filtration Rate (Kidney Function)   [ Time Frame: 2 years ]


  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
No text entered.


  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. Neera Dahl
Organization: Yale University School of Medicine
phone: 203-785-4184
e-mail: neera.dahl@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00920309     History of Changes
Other Study ID Numbers: HIC#0903004934
First Submitted: June 12, 2009
First Posted: June 15, 2009
Results First Submitted: August 29, 2013
Results First Posted: April 14, 2014
Last Update Posted: April 14, 2014