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

Official Title:

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
Phase 3 Interventional 18 Years and older Quark Pharmaceuticals QRK306
NCT02610296
Enrolling patients

Study Design:


Principal Investigator

Professor of Surgery
Division of Transplant Surgery
Director, Abdominal Transplant Fellowship Program

Clinical Research Coordinator

UCSF Medical Center at Parnassus
(415) 514-0192 Phone

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

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).

Detailed Description

This is a Phase 3 randomized, placebo-controlled, double-blind, multi-center trial
stratified by donor age and by region to evaluate the reduction in incidence and severity of
delayed graft function with kidney allografts from DBD donors who were at least 45 years of
age.

Important

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.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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