Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00413777
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-18
Brief Title:
Tolvaptan Open-label Pilot Efficacy Tolerability and Safety Study in Autosomal Dominant Polycystic Kidney Disease ADPKD
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Phase 2 Multi-center Open-label Study to Determine Long-term Safety Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mgd in Patients With Autosomal Dominant Polycystic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2017-05
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:
TEMPO 24
Brief Summary:
This studys purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease ADPKD
Detailed Description:
Autosomal Dominant Polycystic Kidney Disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys The accumulation of these cysts causes the kidneys to enlarge several times the normal size and leads to the eventual loss of renal function and ultimately results in renal failure in end-stage patients This is a disease with life-threatening implications to those who have it and their family members who may also be affected Aside from early anti-hypertensive control and dietary protein restriction which are presumed to offer a modest degree of protection most surviving patients require renal replacement therapy dialysis and transplant and suffer from high morbidity and mortality
A rationale for use of tolvaptan in these genetic disorders has been proven in principle through use of a variety of animal models In these models tolvaptan is effective in halting or reversing the progression of this renal disease
The current study is being undertaken in order to evaluate whether tolvaptan an oral vasopressin V2 receptor inhibitor will maintain an adequate safety profile and show a potential clinical benefit by reducing total renal volume in the hopes of making an impact upon disease progression
A rationale for use of tolvaptan in these genetic disorders has been proven in principle through use of a variety of animal models In these models tolvaptan is effective in halting or reversing the progression of this renal disease
The current study is being undertaken in order to evaluate whether tolvaptan an oral vasopressin V2 receptor inhibitor will maintain an adequate safety profile and show a potential clinical benefit by reducing total renal volume in the hopes of making an impact upon disease progression
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