QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant

Trial Summary

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

Eligibility

• Has the ability to understand the requirements of the study, is able to provide
  written informed consent and is willing and able to comply with the requirements of
  the study protocol.
• Male or female at least 18 years of age.
• Has dialysis dependent renal failure initiated at least 2 months prior to
  transplantation.
• Is to be a recipient of a transplant from a deceased donor (brain death criteria) ≥ 45
  years of age.
• Based on donor age, the following requirements for the risk of DGF (determined using
  the Irish DGF risk assessment nomogram) and cold ischemia time (CIT) must be met:
      - Donor age 45 - 59 years: estimated DGF risk ≥ 20% and estimated CIT ≥ 10 hour
      - Donor age ≥ 60 years: no minimum estimated DGF risk or minimum estimated CIT
• Is able to comply with the requirement of antibody induction therapy with rabbit
  polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per
  center standard of care.
• Must be up-to-date on cancer screening according to site-specific guidelines and past
  medical history must be negative for biopsy-confirmed malignancy within 5 years of
  randomization, with the exception of adequately treated basal cell or squamous cell
  carcinoma in situ or carcinoma of the cervix in situ.

• Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD)
  donor.
• Recipient of donor kidney preserved with normothermic machine perfusion.
• Scheduled to undergo multiorgan transplantation.
• Has a planned transplant of kidneys that are implanted en bloc (dual kidney
  transplant).
• Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
• Has lost first kidney transplant due to graft thrombosis.
• Is scheduled for transplantation of a kidney from a donor who is known to have
  received an investigational therapy under another IND/CTA for ischemic/reperfusion
  injury immediately prior to organ recovery.
• Is scheduled to receive an ABO-incompatible donor kidney.
• Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method
  or CDC crossmatch method, if performed.
• Has a positive T- or B-cell flow cross-match AND donor specific anti-HLA antibody
  (DSA) detected by flow cytometry, Luminex® based antigen-specific anti-HLA antibody
  testing, or by similar methodology, if performed.
• Has undergone desensitization to remove donor specific anti-HLA antibodies prior to
  transplantation.
• Has participated in an investigational study within the last 30 days or received an
  investigational product within 5 half-lives of the study drug administration,
  whichever is longest.
• Has known allergy to or has participated in a prior study with siRNA.
• Has a history of HBV (Note: subjects with a serological profile suggestive of
  clearance, or prior antiviral treatment of a prior HBV infection, may be enrolled with
  the approval of the Medical Monitor).
• Has a history of HIV.
• Recipient of a known HIV positive donor kidney.
• Is HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion
  of treatment with an approved antiviral regimen and who remain free of HCV as
  determined by HCV RNA testing may be enrolled. Subjects who have been cleared of HCV
  virus after treatment with an unapproved regimen should be approved by the Medical
  Monitor).

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.