Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346918
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2006-06-22
Brief Title:
Sirolimus Rapamune for Autosomal Dominant Polycystic Kidney Disease ADPKD
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Sirolimus Rapamune for Patients With Autosomal Dominant Polycystic Kidney Disease ADPKD a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2014-02
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 aim of our study is to investigate whether Rapamune used at a low dose 2 mgd retards cyst growth and slows renal functional deterioration in patients with ADPKD
Detailed Description:
Currently there is no treatment for ADPKD other than supportive care and blood pressure control Usually dialytic treatment or renal transplantation becomes necessary when the disease has progressed to end-stage renal failureWe and others could demonstrate that rapamycin a classical mTOR inhibitor retards cyst growth and preserves renal function in a rodent model of ADPKD The aim of our study is to investigate whether Rapamune 2 mgd retards cyst growth and slows renal functional deterioration in patients with ADPKD We anticipate that we can slow disease progression and delay the need for chronic renal replacement therapy by the inhibition of mTOR with Rapamune This is a 24-month prospective controlled open label study with 2 parallel groups in patients with ADPKD Patients will be randomized at a 11 ratio to one of the 2 treatment arms Primary endpoint is percentage change of renal volume measured by high resolution magnetic resolution imaging
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