|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Quark Pharmaceuticals |
|---|---|
| Information provided by: | Quark Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00802347 |
Purpose
The purpose of this study is to determine whether a single administration of 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 8:2 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, approximately 200 patients will participate at approximately 40 sites; 100 patients will be randomized to receive I5NP and 100 patients randomized to receive placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Delayed Graft Function Kidney Transplant |
Drug: I5NP Drug: Saline |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, 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 |
| Estimated Enrollment: | 240 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| I5NP: Experimental |
Drug: I5NP
Single IV injection of I5NP Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg Part B: highest or maximum tolerated dose from Part A (up to 10.0 mg/kg) |
| Saline: Placebo Comparator |
Drug: Saline
Single IV injection of saline Part A: dose-escalation study; cohort 1 = 0.5 mg/kg; cohort 2 = 1.5 mg/kg; cohort 3 = 5.0 mg/kg; cohort 4 = 10.0 mg/kg Part B: up to 10.0 mg/kg |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Health Science Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Lifelink Healthcare Institute | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| University of Illinois Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Wake Forest University Medical Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| The Christ Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| Baylor All Saints Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Study Director: | Martin S. Polinsky, MD | Quark Pharmaceuticals |
More Information
| Responsible Party: | Quark Pharmaceuticals, Inc. ( Mike Johnston, Director of Regulatory Affairs ) |
| Study ID Numbers: | QRK.006 |
| Study First Received: | December 2, 2008 |
| Last Updated: | January 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00802347 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Delayed Graft Function Kidney Transplant Renal Transplant small interfering ribonucleic acid (siRNA) |
|
Pathologic Processes Delayed Graft Function |