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Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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ClinicalTrials.gov Identifier: NCT00456365
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Polycystic Kidney, Autosomal Dominant
Interventions: Drug: pravastatin
Drug: 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
Pravastatin

Pravastatin

pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)

Placebo

Placebo

Placebo: Placebo daily


Participant Flow:   Overall Study
    Pravastatin   Placebo
STARTED   56   54 
COMPLETED   49   42 
NOT COMPLETED   7   12 
Lost to Follow-up                1                3 
Withdrawal by Subject                4                7 
Pregnancy                1                1 
oncologic diagnosis                1                1 



  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.
A total of 111 participants were screened with 110 enrolled in this clinical trial, including 56 randomized to pravastatin and 54 randomized to placebo.

Reporting Groups
  Description
Pravastatin

Pravastatin

pravastatin: Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)

Placebo

Placebo

Placebo: Placebo daily

Total Total of all reporting groups

Baseline Measures
   Pravastatin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   54   110 
Age 
[Units: Years]
Mean (Standard Deviation)
 16  (4)   16  (4)   16  (4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  60.7%      34  63.0%      68  61.8% 
Male      22  39.3%      20  37.0%      42  38.2% 
Region of Enrollment 
[Units: Participants]
     
United States   56   54   110 
Total kidney volume corrected for height [1] 
[Units: Ml/m]
Mean (Standard Deviation)
 336  (187)   315  (175)   326  (181) 
[1] Total kidney volume corrected for height (HtTKV, ml/m)
Urinary albumin excretion [1] 
[Units: Mcg/min]
Mean (Standard Deviation)
 27  (37)   51  (123)   39  (79) 
[1] Urinary albumin excretion in mcg/min
Left ventricular mass index [1] 
[Units: G/m^2]
Mean (Standard Deviation)
 55  (12)   53  (10)   54  (11) 
[1] Left ventricular mass index in g/m^2 by MRI
Total cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 145  (30)   151  (27)   148  (29) 
LDL cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 84  (23)   90  (21)   86  (22) 


  Outcome Measures

1.  Primary:   Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume   [ Time Frame: 3 years ]

2.  Secondary:   Percentage Change in Total Kidney Volume Corrected for Height   [ Time Frame: 3 years ]

3.  Secondary:   Left Ventricular Mass Index   [ Time Frame: 3 years ]

4.  Secondary:   Urinary Albumin Excretion   [ Time Frame: 3 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: Melissa Cadnapaphornchai, MD
Organization: PKD Research Group, University of Colorado Anschutz Medical Campus
phone: 3037241690
e-mail: pkd@ucdenver.edu


Publications:


Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00456365     History of Changes
Other Study ID Numbers: 05-0704
2R01DK058793 ( U.S. NIH Grant/Contract )
First Submitted: March 12, 2007
First Posted: April 4, 2007
Results First Submitted: May 27, 2014
Results First Posted: March 9, 2018
Last Update Posted: March 9, 2018