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

Completed · Phase 3 · Has a placebo group

Conditions studied: Delayed Graft Function

In brief

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).

Key facts

Study ID

NCT02610296

Run by

Quark Pharmaceuticals

People needed

594

Starts

2016-03-01

Expected to finish

2019-01-08

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Mayo Clinic Phoenix — Phoenix, Arizona, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Georgetown Transplant Institute — Washington D.C., District of Columbia, United States
• University of Florida Health, Shands Hospital — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Barnabas Medical Center — Livingston, New Jersey, United States
• Erie County Medical Center — Buffalo, New York, United States
• Icahn School of Medicine at Mt. Sinai — New York, New York, United States
• Columbia University — New York, New York, United States
• New York - Presbyterian Hospital / Weill Cornell Medical Center — New York, New York, United States
• SUNY Upstate NY University Hospital — Syracuse, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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