A Dose Escalation and Safety Study of I5NP to Prevent Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation, Part A

Trial Summary

This is a Phase I/II, randomized, double-blind, dose escalation, safety and PK study. The study will be conducted in approximately 15 sites in the United States. In Part A, up to 42 patients undergoing deceased donor kidney transplantation will participate. Patients will receive a single IV injection of I5NP or placebo. I5NP (or placebo) will be administered approximately 30 minutes following reperfusion of the graft (final re-establishment of good blood flow to the graft) and achievement of hemostasis. The duration of the study is approximately 180 days.

Eligibility

• Patient is at least 18 years of age
• Patient has given informed consent
• Patient is willing to comply with protocol
• Patient is willing to practice birth control for the duration of the study (180 days)
• Women of childbearing potential test negative for pregnancy (either urine or serum)
  within 48 hours prior to transplant
• Patient is up-to-date on cancer screening according to site-specific guidelines
• Recipient of donor kidney transplant from ECD with brain death, or from DCD, or from
  SCD with cold ischemia time (CIT ) > 24 hours
• Patient is dialysis dependent at the time of transplant by: a) at least 2 dialysis
  sessions/week in the 56 days prior to transplant, or b) removal of remaining nephron
  mass at time of transplant, or c) the opinion of the investigator that the patient's
  renal function has been permanently eliminated

• Patient has participated in an investigational drug study in the last 30 days
• Patient has known allergy or has participated in prior study with siRNA
• Patient is HCV-positive and has liver function tests (ALT, AST or bilirubin) >1.5
  ULN; patient plans to receive an HCV-positive kidney
• Patient is planned to receive multiorgan transplant
• Patient has a planned transplant of kidneys that are implanted en bloc (dual kidney
  transplant)
• Patient has planned transplant of kidneys from donors < 6 years of age
• Patient has planned transplant of dual kidneys (from the same donor) transplanted not
  en bloc (as in the case of dual ECD donor kidneys)
• Patient has a planned transplant 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
• Patient is planned to receive a living donor kidney
• Patient is planned to receive an ABO-incompatible donor kidney
• Patient is planned to receive an organ from a DCD donor that also meets the criteria
  for an ECD donor
• 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

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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