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

NCT02610296 | Completed Phase 3 DMC

• 1 other identifier: QRK306
• Study Type: interventional
• Target: 594
• Locations: 11 countries
• Sites: 84

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).

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.

  Day 0 to Day 7

• 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

Study Arms (2)

QPI-1002

ACTIVE COMPARATOR

QPI-1002 Injection, single dose

Drug: QPI-1002

Placebo

PLACEBO COMPARATOR

isotonic saline

Other: Placebo

Interventions

QPI-1002 DRUG

IV injection

QPI-1002

Placebo OTHER

isotonic saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Quark Pharmaceuticals: lead

Study Sites (84)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic Phoenix

Phoenix, Arizona, 85054, United States

Location

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Georgetown Transplant Institute

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida Health, Shands Hospital

Gainesville, Florida, 32608, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Maryland

Baltimore, Maryland, 21202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

New York - Presbyterian Hospital / Weill Cornell Medical Center

New York, New York, 10065, United States

Location

SUNY Upstate NY University Hospital

Syracuse, New York, 13210, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27103, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Integris Nazih Zuhdi Transplant Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Baylor All Saints

Fort Worth, Texas, 76104, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Hospital Universitario Austral

Buenos Aires, 1500, Argentina

Location

Instituto de Nefrología Trasplante Renal y Renopancreatico

Buenos Aires, 3889, Argentina

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier - Universitaire de Liège

Liège, 4000, Belgium

Location

Hospital Geral de Fortaleza

Fortaleza, Ceará, 60156-290, Brazil

Location

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Pernambuco, 50070-550, Brazil

Location

Hospital São Francisco de Assis

Rio de Janeiro, Rio de Janeiro, 20530-001, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, São Paulo, 04038-002, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Klinika nefrologie IKEM

Prague, 140 24, Czechia

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hospital Henri Mondor - Créteil

Créteil, 94010, France

Location

Centre Hospitalier Universitaire de Grenoble

La Tronche, 38700, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Hôpital Pasteur

Nice, 06001, France

Location

Hôpital Necker

Paris, 75015, France

Location

Centre Hospitalier Universitaire de Rangueil

Toulouse, 31059, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen

Hanover, 30625, Germany

Location

University Hospital Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Tübingen

Tübingen, D-72076, Germany

Location

University Medical Center Groningen

Groningen, 9713, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333, Netherlands

Location

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46600, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Holman, M.D.,Ph.D.

  Quark Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: March 1, 2016
• Primary Completion: June 28, 2018
• Study Completion: January 8, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

BR (7); US (36); NL (3); ES (9); BE (2); AR (2); CA (4); CZ (1); FR (7); AU (5); DE (8)