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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
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description

Pravastatin

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

Placebo

Placebo: Placebo daily

Period Title: Overall Study
Started 56 54
Completed 49 42
Not Completed 7 12
Reason Not Completed
Lost to Follow-up             1             3
Withdrawal by Subject             4             7
Pregnancy             1             1
oncologic diagnosis             1             1
Arm/Group Title Pravastatin Placebo Total
Hide Arm/Group Description

Pravastatin

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

Placebo

Placebo: Placebo daily

Total of all reporting groups
Overall Number of Baseline Participants 56 54 110
Hide Baseline Analysis Population Description
A total of 111 participants were screened with 110 enrolled in this clinical trial, including 56 randomized to pravastatin and 54 randomized to placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 54 participants 110 participants
16  (4) 16  (4) 16  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 54 participants 110 participants
Female
34
  60.7%
34
  63.0%
68
  61.8%
Male
22
  39.3%
20
  37.0%
42
  38.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants 54 participants 110 participants
56 54 110
Total kidney volume corrected for height   [1] 
Mean (Standard Deviation)
Unit of measure:  Ml/m
Number Analyzed 56 participants 54 participants 110 participants
336  (187) 315  (175) 326  (181)
[1]
Measure Description: Total kidney volume corrected for height (HtTKV, ml/m)
Urinary albumin excretion   [1] 
Mean (Standard Deviation)
Unit of measure:  Mcg/min
Number Analyzed 56 participants 54 participants 110 participants
27  (37) 51  (123) 39  (79)
[1]
Measure Description: Urinary albumin excretion in mcg/min
Left ventricular mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  G/m^2
Number Analyzed 56 participants 54 participants 110 participants
55  (12) 53  (10) 54  (11)
[1]
Measure Description: Left ventricular mass index in g/m^2 by MRI
Total cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 56 participants 54 participants 110 participants
145  (30) 151  (27) 148  (29)
LDL cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 56 participants 54 participants 110 participants
84  (23) 90  (21) 86  (22)
1.Primary Outcome
Title Percent of Participants Demonstrating 20% or More Increase in Total Kidney Volume
Hide Description Percent of participants demonstrating 20% or more increase in total kidney volume corrected for height, left ventricular mass index, or urinary albumin excretion over the three year study period
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description:

Pravastatin

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

Placebo

Placebo: Placebo daily

Overall Number of Participants Analyzed 49 42
Measure Type: Number
Unit of Measure: percentage of participants
69 88
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pravastatin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change in Total Kidney Volume Corrected for Height
Hide Description [Not Specified]
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description:

Pravastatin

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

Placebo

Placebo: Placebo daily

Overall Number of Participants Analyzed 49 42
Mean (Standard Deviation)
Unit of Measure: Percent change
23  (3) 31  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pravastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Left Ventricular Mass Index
Hide Description left ventricular mass index in g/m^2 by MRI
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description:
Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
Placebo daily
Overall Number of Participants Analyzed 49 42
Mean (Standard Deviation)
Unit of Measure: g/m^2
60  (15) 58  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pravastatin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Urinary Albumin Excretion
Hide Description [Not Specified]
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description:
Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years)
Placebo daily
Overall Number of Participants Analyzed 49 42
Mean (Standard Deviation)
Unit of Measure: mcg/min
29  (39) 49  (99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pravastatin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pravastatin Placebo
Hide Arm/Group Description Pravastatin 20 mg daily (subject age 8-12 years) or 40 mg daily (subject age 13-21 years) Placebo daily
All-Cause Mortality
Pravastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pravastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pravastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/54 (0.00%) 
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
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