Ignite Creation Date:
2024-05-05 @ 9:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00802347
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2008-12-02
Brief Title:
I5NP for Prophylaxis of Delayed Graft Function in Kidney Transplantation
Sponsor:
Quark Pharmaceuticals
Organization:
Quark Pharmaceuticals
Study Overview
Official Title:
Controlled Randomized Prospective Double-Blind Multicenter Phase III Dose-Escalation Study of the Safety PK and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2014-09
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 a single administration of QPI-1002 also known as I5NP can prevent DGF in patients undergoing deceased donor kidney transplantation In this Phase I II study patients who are undergoing renal transplantation with organs from DCD donors ECD donors or SCD donors with 24 hours of cold ischemia time who meet study entry criteria will be studied to evaluate the safety and pharmacokinetic profile of I5NP Part A and clinical activity of I5NP administration Part B Data from this study will be used to identify doses of I5NP to be used in follow-on efficacy studies
Part A will be a randomized dose escalation study to determine the highest or maximum tolerated dose MTD Part A will enroll 40 patients at approximately 20 sites patients will be randomized to receive either I5NP or placebo in a ratio of 82 in each cohort cohorts 1-4
Part B will utilize the dose identified in Part A to further evaluate in a double-blind manner the safety and clinical activity of I5NP In Part B up to 326 patients will participate at approximately 60 sites up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo
Part A will be a randomized dose escalation study to determine the highest or maximum tolerated dose MTD Part A will enroll 40 patients at approximately 20 sites patients will be randomized to receive either I5NP or placebo in a ratio of 82 in each cohort cohorts 1-4
Part B will utilize the dose identified in Part A to further evaluate in a double-blind manner the safety and clinical activity of I5NP In Part B up to 326 patients will participate at approximately 60 sites up to 163 patients will be randomized to receive I5NP and up to 163 patients randomized to receive placebo
Detailed Description:
Although the etiology of DGF is not fully understood and may be multifactorial the pathophysiology appears to be primarily related to ischemia-reperfusion IR injury resulting from organ preservation between the times of harvesting from the donor and reperfusion following vascular reanastomosis in the recipient
I5NP is a small interfering RNA siRNA that is being developed for the prophylaxis of delayed graft function DGF in patients receiving renal transplants
I5NP is a small interfering RNA siRNA that is being developed for the prophylaxis of delayed graft function DGF in patients receiving renal transplants
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