Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06291116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Brief Title:
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
ETERNAL-PKD
Brief Summary:
Autosomal dominant polycystic kidney disease ADPKD is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2 Patients develop renal cysts with progressive impairment of renal function leading to renal failure terminal renal failure for 13 of them These patients also present early with high blood pressure and cardiovascular complications notably intracerebral aneurysms This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions
Experimental results suggested that stimulation of dopamine receptor type 5 DR5 could restore the mechanosensitivity of endothelial cells a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD through restoration of endothelial NO release upon increased blood flow Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine a dopamine agonist administered via transdermal patches for 2 months at a low dose 4 mg24h
Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels
This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact
Experimental results suggested that stimulation of dopamine receptor type 5 DR5 could restore the mechanosensitivity of endothelial cells a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD through restoration of endothelial NO release upon increased blood flow Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine a dopamine agonist administered via transdermal patches for 2 months at a low dose 4 mg24h
Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels
This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None