QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant (ReGIFT)
Primary Purpose
Delayed Graft Function
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
QPI-1002
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Delayed Graft Function
Eligibility Criteria
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).
Sites / Locations
- University of Alabama at Birmingham
- Mayo Clinic Phoenix
- University of California, Los Angeles
- University of Southern California
- University of California, Davis
- California Pacific Medical Center
- University of California, San Francisco
- Stanford University
- University of Colorado, Denver
- Yale University
- Georgetown Transplant Institute
- University of Florida Health, Shands Hospital
- Tampa General Hospital
- Emory University
- University of Louisville
- Ochsner Medical Center
- University of Maryland
- University of Michigan
- St. Barnabas Medical Center
- Erie County Medical Center
- Icahn School of Medicine at Mt. Sinai
- Columbia University
- New York - Presbyterian Hospital / Weill Cornell Medical Center
- SUNY Upstate NY University Hospital
- Duke University
- Wake Forest University
- Ohio State University
- Integris Nazih Zuhdi Transplant Institute
- Medical University of South Carolina
- Baylor University Medical Center
- Baylor All Saints
- Houston Methodist Hospital
- University of Virginia
- Virginia Commonwealth University
- University of Washington
- University of Wisconsin
- Hospital Universitario Austral
- Instituto de Nefrología Trasplante Renal y Renopancreatico
- John Hunter Hospital
- Westmead Hospital
- Princess Alexandra Hospital
- Royal Adelaide
- Royal Melbourne Hospital
- UZ Leuven - Campus Gasthuisberg
- Centre Hospitalier - Universitaire de Liège
- Hospital Geral de Fortaleza
- Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
- Hospital São Francisco de Assis
- Santa Casa de Misericordia de Porto Alegre
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
- Fundação Oswaldo Ramos - Hospital do Rim
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- St. Paul's Hospital
- Queen Elizabeth II Health Sciences Centre
- St. Michael's Hospital
- McGill University Health Centre
- Klinika nefrologie IKEM
- Hôpital Pellegrin
- Hospital Henri Mondor - Créteil
- Centre Hospitalier Universitaire de Grenoble
- Hôpital Edouard Herriot
- Hôpital Pasteur
- Hôpital Necker
- Centre Hospitalier Universitaire de Rangueil
- Charité - Universitätsmedizin Berlin
- Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)
- Universitätsklinikum Bonn
- Universitätsklinikum Carl Gustav Carus Dresden
- Universitätsklinikum Hamburg-Eppendorf
- Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen
- University Hospital Schleswig Holstein, Campus Kiel
- Universitätsklinikum Tübingen
- University Medical Center Groningen
- Leids Universitair Medisch Centrum
- Maastricht University Medical Centre
- Hospital Universitari Germans Trias i Pujol
- Hospital Universitari de Bellvitge
- Hospital Universitario Marqués de Valdecilla
- Hospital del Mar
- Hospital Universitari Vall d´Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario 12 de Octubre
- Hospital Universitario Doctor Peset
- Hospital Universitario Miguel Servet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
QPI-1002
Placebo
Arm Description
QPI-1002 Injection, single dose
isotonic saline
Outcomes
Primary Outcome Measures
The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
Secondary Outcome Measures
The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
The proportion of subjects with a decrease in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02610296
Brief Title
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
Acronym
ReGIFT
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
January 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quark Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Graft Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
594 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QPI-1002
Arm Type
Active Comparator
Arm Description
QPI-1002 Injection, single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
isotonic saline
Intervention Type
Drug
Intervention Name(s)
QPI-1002
Intervention Description
IV injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
isotonic saline
Primary Outcome Measure Information:
Title
The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
Time Frame
Day 0 to Day 30
Secondary Outcome Measure Information:
Title
The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
Time Frame
Day 0 to Day 7
Title
The proportion of subjects with a decrease in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant.
Time Frame
Day 0 to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Holman, M.D.,Ph.D.
Organizational Affiliation
Quark Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Georgetown Transplant Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Florida Health, Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Icahn School of Medicine at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York - Presbyterian Hospital / Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
SUNY Upstate NY University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Integris Nazih Zuhdi Transplant Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor All Saints
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Hospital Universitario Austral
City
Buenos Aires
ZIP/Postal Code
1500
Country
Argentina
Facility Name
Instituto de Nefrología Trasplante Renal y Renopancreatico
City
Buenos Aires
ZIP/Postal Code
3889
Country
Argentina
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier - Universitaire de Liège
City
Liège 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hospital Geral de Fortaleza
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60156-290
Country
Brazil
Facility Name
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
City
Recife
State/Province
PE
ZIP/Postal Code
50070-550
Country
Brazil
Facility Name
Hospital São Francisco de Assis
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20530-001
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-074
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Fundação Oswaldo Ramos - Hospital do Rim
City
São Paulo
State/Province
SP
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Klinika nefrologie IKEM
City
Praha 4
ZIP/Postal Code
140 24
Country
Czechia
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospital Henri Mondor - Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hôpital Pasteur
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Universitaire de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital Schleswig Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
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