QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
NCT ID: NCT02610296
Last Updated: 2020-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
594 participants
INTERVENTIONAL
2016-03-01
2019-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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QPI-1002
QPI-1002 Injection, single dose
QPI-1002
IV injection
Placebo
isotonic saline
Placebo
isotonic saline
Interventions
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QPI-1002
IV injection
Placebo
isotonic saline
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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John Holman, M.D.,Ph.D.
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Integris Nazih Zuhdi Transplant Institute
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor All Saints
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Universitario Austral
Buenos Aires, , Argentina
Instituto de Nefrología Trasplante Renal y Renopancreatico
Buenos Aires, , Argentina
John Hunter Hospital
New Lambton, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
UZ Leuven - Campus Gasthuisberg
Leuven, , Belgium
Centre Hospitalier - Universitaire de Liège
Liège, , Belgium
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Pernambuco, Brazil
Hospital São Francisco de Assis
Rio de Janeiro, Rio de Janeiro, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
St. Paul's Hospital
Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Klinika nefrologie IKEM
Prague, , Czechia
Hôpital Pellegrin
Bordeaux, , France
Hospital Henri Mondor - Créteil
Créteil, , France
Centre Hospitalier Universitaire de Grenoble
La Tronche, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Pasteur
Nice, , France
Hôpital Necker
Paris, , France
Centre Hospitalier Universitaire de Rangueil
Toulouse, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen
Hanover, , Germany
University Hospital Schleswig Holstein, Campus Kiel
Kiel, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
University Medical Center Groningen
Groningen, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
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Other Identifiers
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QRK306
Identifier Type: -
Identifier Source: org_study_id
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