Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study in order to assess the Safety, the behaviour of the investigational product in the human body and the Clinical Activity of I5NP to prevent Delayed Graft Function in Patients Undergoing Kidney Transplantation from deceased donors

• Conditions: I5NP is being developed for the prophylaxis of delayed graft function (DGF) in patients receiving renal transplants. The patient population of the current study will include patients undergoing deceased donor renal transplantation who are at risk for DGF.; MedDRA version: 13.1Level: LLTClassification code 10048747Term: Renal graft function delayedSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2010-020989-20-DE
• Lead Sponsor: Quark Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-23
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Part B (the subject trial portion):
1. Patient is at least 18 years of age.
2. Patient has given informed consent.
3. Patient is willing to practice birth control. Female / Male
4. Women of childbearing potential test negative for pregnancy (either urine or serum) within 48 hours prior to transplant.
5. Patient is up-to-date on cancer screening according to site-specific guidelines and the past medical history is negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ.
6. Patient is scheduled to receive kidney transplant from a deceased donor meeting the following criteria
Part B exclusive:
• Receipt of an ECD kidney that has been preserved by cold storage (ECD/CS) for the entire period of cold ischemia time (CIT)*, regardless of duration
• Receipt of an ECD kidney that has been preserved by machine perfusion (ECD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours
• Receipt of an SCD kidney that has been preserved by cold storage (SCD/CS) where total CIT* has been at least 26 hours
• Receipt of an SCD kidney that has been preserved by machine perfusion (SCD/MP**) for any interval of time during the period of cold ischemia, where total CIT* has been at least 26 hours.
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*CIT will be estimated at screening based on the difference between the time of aortic cross-clamping in the donor and projected initiation of the arterial anastomotic procedure in the recipient)
**For purposes of this study, a kidney that has been preserved by machine perfusion” means that the kidney has had any machine preservation (e.g. a kidney that was initially machine perfused but then removed from the pump and placed on cold storage, would be considered MP).

7. Patient is dialysis dependent at the time of transplant as documented by at least one of the following:
• the requirement for at least 2 dialysis sessions/week during the 56 days prior to transplant, or
• the planned removal of any remaining native kidney at the time of transplant, or
• the investigator has provided documentation to the Medical Monitor that the patient has no remaining native renal function (e.g., documentation that the patient is anuric, with urine output <50 mL/day)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 261
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. Patient has participated in an investigational drug study in the last 30 days.
2. Patient has known allergy or has participated in prior study with siRNA.
3. Patient is HCV-positive
4. Patient is HIV-positive
5. Patient is scheduled to undergo multiorgan transplantation.
6. Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
7. Patient has planned transplant of kidneys from donors < 6 years of age.
8. Patient has planned transplant of dual kidneys (from the same donor) transplanted not en bloc (as in the case of dual ECD donor kidneys).
9. Patient is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another IND) for ischemic/reperfusion injury immediately prior to organ recovery.
10. Patient is scheduled to receive a living donor kidney.
11. Patient is scheduled to receive an ABO-incompatible donor kidney.
12. Patient is scheduled to receive an organ from a donor that meets both DCD and ECD criteria[1].
13. Patient is scheduled to receive an organ from a donor that meets DCD criteria (exclusion applicable to Part B only)
14. Patient has history or presence of a medical condition or disease that in the investigator’s assessment would place the patient at an unacceptable risk for study participation.

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[1] ECD is defined as deceased donors 60 years of age or donors 50-59 years of age with at least two of the following: history of hypertension (HTN), death due to cerebrovascular accident (CVA) or terminal serum creatinine (SCr) >1.5 mg/dL.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified