A Study of the Safety and Effectiveness of QPI-1002 for the Prevention of Delayed Graft Function in Transplant Recipients from Older Kidney Donors who have Died


About this study

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function when using QPI-1002 with kidney transplants from donors older than 45 years who have brain death.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).


Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amit Mathur, M.D.

Closed for enrollment

More information


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Additional contact information

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