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| Sponsor: | Quark Pharmaceuticals |
|---|---|
| Information provided by (Responsible Party): | 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, 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Delayed Graft Function Other Complication of Kidney Transplant |
Drug: I5NP Drug: Saline |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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: | 366 |
| 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 |
|---|---|
| Experimental: I5NP |
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: 10.0 mg/kg Other Name: QPI-1002
|
| Placebo Comparator: Saline |
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: 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:
Patient is scheduled to receive kidney transplant from a deceased donor meeting the following criteria:
Part A:
Part B:
Exclusion Criteria:
Contacts and Locations| Contact: Shawna Bredek | 513-598-9290 | sbredek@ctifacts.com |
Show 62 Study Locations| Study Director: | Martin S. Polinsky, MD | Quark Pharmaceuticals |
More Information
| Responsible Party: | Quark Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00802347 History of Changes |
| Other Study ID Numbers: | QRK.006 |
| Study First Received: | December 2, 2008 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - French Health Products Safety Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios |
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Delayed Graft Function Kidney Transplant Renal Transplant small interfering ribonucleic acid (siRNA) |
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Delayed Graft Function Pathologic Processes |