Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456365
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2007-03-12
Brief Title:
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease ADPKD
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease ADPKD
Detailed Description:
Autosomal dominant polycystic kidney disease ADPKD is the most common hereditary kidney disease affecting 1 in 400 to 1000 individuals and accounting for 4 of end-stage renal disease in the United States and 8-10 in Europe The condition is characterized by progressive development of kidney cysts with kidney enlargement and associated loss of kidney function High blood pressure and cardiovascular disease are common in patients with ADPKD Although the condition is often thought to affect primarily adults it is clear that the disease can be present in the fetus and young children
This study was designed to determine if treatment with the medicine pravastatin can slow the progression of kidney and heart disease when initiated early in life in patients with ADPKD The Investigators will assess differences between pravastatin and placebo study groups over the three-year study period with respect to 1 total kidney volume as assessed by magnetic resonance imaging MRI 2 left ventricular mass index as assessed by MRI 3 urinary albumin excretion and 4 endothelial-dependent vasodilation as assessed by brachial ultrasound A total of 110 subjects were enrolled in this research study This study involved pediatric subjects because the Investigators believe that early intervention is critical if they are to decrease the morbidity and mortality associated with this condition If pravastatin is shown to be effective in ameliorating progression of renal and cardiovascular disease in this study routine management of people with this condition will be drastically altered
This study was designed to determine if treatment with the medicine pravastatin can slow the progression of kidney and heart disease when initiated early in life in patients with ADPKD The Investigators will assess differences between pravastatin and placebo study groups over the three-year study period with respect to 1 total kidney volume as assessed by magnetic resonance imaging MRI 2 left ventricular mass index as assessed by MRI 3 urinary albumin excretion and 4 endothelial-dependent vasodilation as assessed by brachial ultrasound A total of 110 subjects were enrolled in this research study This study involved pediatric subjects because the Investigators believe that early intervention is critical if they are to decrease the morbidity and mortality associated with this condition If pravastatin is shown to be effective in ameliorating progression of renal and cardiovascular disease in this study routine management of people with this condition will be drastically altered
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01DK058793 | NIH | None | httpsreporternihgovquickSearch2R01DK058793 |