QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
- Registration Number
- NCT02610296
- Lead Sponsor
- Quark Pharmaceuticals
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 594
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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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QPI-1002 QPI-1002 QPI-1002 Injection, single dose Placebo Placebo isotonic saline
- Primary Outcome Measures
Name Time Method The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant. Day 0 to Day 30
- Secondary Outcome Measures
Name Time Method The proportion of subjects with a decrease in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant. Day 0 to Day 7 The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant. Day 0 to Day 7
Trial Locations
- Locations (84)
Centre Hospitalier - Universitaire de Liège
🇧🇪Liège 1, Belgium
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Erie County Medical Center
🇺🇸Buffalo, New York, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Stanford University
🇺🇸Stanford, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University Hospital Schleswig Holstein, Campus Kiel
🇩🇪Kiel, Germany
Hospital São Francisco de Assis
🇧🇷Rio de Janeiro, RJ, Brazil
Columbia University
🇺🇸New York, New York, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Centre Hospitalier Universitaire de Grenoble
🇫🇷La Tronche, France
Hôpital Pasteur
🇫🇷Nice, France
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
University of Florida Health, Shands Hospital
🇺🇸Gainesville, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hôpital Edouard Herriot
🇫🇷Lyon, France
Hôpital Necker
🇫🇷Paris, France
Baylor All Saints
🇺🇸Fort Worth, Texas, United States
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Centre Hospitalier Universitaire de Rangueil
🇫🇷Toulouse, France
Hospital Geral de Fortaleza
🇧🇷Fortaleza, CE, Brazil
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
🇧🇷Recife, PE, Brazil
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Klinika nefrologie IKEM
🇨🇿Praha 4, Czechia
Instituto de Nefrología Trasplante Renal y Renopancreatico
🇦🇷Buenos Aires, Argentina
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)
🇩🇪Berlin, Germany
Hospital Universitari Vall d´Hebron
🇪🇸Barcelona, Spain
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen
🇩🇪Hannover, Germany
Hospital Universitario Austral
🇦🇷Buenos Aires, Argentina
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Hospital Henri Mondor - Créteil
🇫🇷Créteil, France
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
University of Southern California
🇺🇸Los Angeles, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Mayo Clinic Phoenix
🇺🇸Phoenix, Arizona, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
SUNY Upstate NY University Hospital
🇺🇸Syracuse, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Integris Nazih Zuhdi Transplant Institute
🇺🇸Oklahoma City, Oklahoma, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
John Hunter Hospital
🇦🇺New Lambton, New South Wales, Australia
Ohio State University
🇺🇸Columbus, Ohio, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Royal Adelaide
🇦🇺Adelaide, South Australia, Australia
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, SP, Brazil
University of Colorado, Denver
🇺🇸Aurora, Colorado, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Georgetown Transplant Institute
🇺🇸Washington, District of Columbia, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Icahn School of Medicine at Mt. Sinai
🇺🇸New York, New York, United States
New York - Presbyterian Hospital / Weill Cornell Medical Center
🇺🇸New York, New York, United States
Santa Casa de Misericordia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, SP, Brazil
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hôpital Pellegrin
🇫🇷Bordeaux, France
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Fundação Oswaldo Ramos - Hospital do Rim
🇧🇷São Paulo, SP, Brazil
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of California, Davis
🇺🇸Sacramento, California, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada