Ignite Creation Date:
2024-05-06 @ 2:29 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02055079
Status:
UNKNOWN
Last Update Posted:
2018-10-31
First Post:
2014-01-31
Brief Title:
Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Pulsed Oral Sirolimus in Autosomal Dominant Polycystic Kidney Disease - The Vienna RAP Study
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
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:
RAP
Brief Summary:
Sirolimus SIR has lead to a reduction of overall kidney size a decrease in cyst density and general tubular cell proliferation in animal models and to a reduction of the increase in creatinine and blood urea nitrogen by 34 and 39 percent respectively as well as a reduction of cyst proliferation expressed by a 30 percent reduction of overall kidney enlargement a reduction in general cyst volume and a reduction of the cyst volume density in the renal cortex in humans
However despite promising data from animal- and in vivo studies most mammalian target of rapamycin inhibitor mTOR-I studies in patients with autosomal-dominant polycystic kidney disease ADPKD produced only subtle if any clinically relevant effects on cyst growth and the preservation of renal function
In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves excretory renal function in patients with ADPKD and an estimated glomerular filtration eGFR rate below 60 mLmin per 173m2
However despite promising data from animal- and in vivo studies most mammalian target of rapamycin inhibitor mTOR-I studies in patients with autosomal-dominant polycystic kidney disease ADPKD produced only subtle if any clinically relevant effects on cyst growth and the preservation of renal function
In this study we will investigate if pulsed administration of SIR in a fixed weekly oral dose of 3 mg over 24 months compared to placebo significantly reduces cyst growth and preserves excretory renal function in patients with ADPKD and an estimated glomerular filtration eGFR rate below 60 mLmin per 173m2
Detailed Description:
None
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 |
|---|---|---|---|
| 10602012 | OTHER | Ethics committee Medical University of Vienna | None |
| 2012-000550-60 | EUDRACT_NUMBER | None | None |
| 15170 | OTHER_GRANT | None | None |