Delayed Graft FunctionPhase 3ReGIFTNCT02610296
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
A Phase 3 study testing QPI-1002 in people with Delayed Graft Function, run by Quark Pharmaceuticals at 84 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- QPI-1002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 594 participants
- Where
- 84 sitesin 11 countries
- Study dates
- 1 Mar 2016to 8 Jan 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
84 sites in 11 countries.
84 sites in 11 countries
United States36 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
University of Colorado, Denver
Aurora, Colorado, 80045
University of Maryland
Baltimore, Maryland, 21202
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Erie County Medical Center
Buffalo, New York, 14215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University
Columbus, Ohio, 43210
Baylor University Medical Center
Dallas, Texas, 75246
Duke University
Durham, North Carolina, 27710
Baylor All Saints
Fort Worth, Texas, 76104
University of Florida Health, Shands Hospital
Gainesville, Florida, 32608
Houston Methodist Hospital
Houston, Texas, 77030
St. Barnabas Medical Center
Livingston, New Jersey, 07039
University of California, Los Angeles
Los Angeles, California, 90024
University of Southern California
Los Angeles, California, 90033
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792
Yale University
New Haven, Connecticut, 06519
Ochsner Medical Center
New Orleans, Louisiana, 70121
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
New York - Presbyterian Hospital / Weill Cornell Medical Center
New York, New York, 10065
Integris Nazih Zuhdi Transplant Institute
Oklahoma City, Oklahoma, 73112
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California, Davis
Sacramento, California, 95817
California Pacific Medical Center
San Francisco, California, 94115
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
SUNY Upstate NY University Hospital
Syracuse, New York, 13210
Tampa General Hospital
Tampa, Florida, 33606
Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007
Wake Forest University
Winston-Salem, North Carolina, 27103
Spain9 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Universitari Vall d´Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Doctor Peset
Valencia, 46600
Hospital Universitario Miguel Servet
Zaragoza, 50009
Germany8 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)
Berlin, 13353
Universitätsklinikum Bonn
Bonn, 53105
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen
Hanover, 30625
University Hospital Schleswig Holstein, Campus Kiel
Kiel, 24105
Universitätsklinikum Tübingen
Tübingen, D-72076
Brazil7 sites
Hospital Geral de Fortaleza
Fortaleza, Ceará, 60156-290
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Pernambuco, 50070-550
Hospital São Francisco de Assis
Rio de Janeiro, Rio de Janeiro, 20530-001
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, São Paulo, 04038-002
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-900
France7 sites
Hôpital Pellegrin
Bordeaux, 33076
Hospital Henri Mondor - Créteil
Créteil, 94010
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700
Hôpital Edouard Herriot
Lyon, 69437
Hôpital Pasteur
Nice, 06001
Hôpital Necker
Paris, 75015
Centre Hospitalier Universitaire de Rangueil
Toulouse, 31059
Australia5 sites
Royal Adelaide
Adelaide, South Australia, 5000
John Hunter Hospital
New Lambton, New South Wales, 2305
Royal Melbourne Hospital
Parkville, Victoria, 3050
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada4 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
McGill University Health Centre
Montreal, Quebec, H4A 3J1
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Netherlands3 sites
University Medical Center Groningen
Groningen, 9713
Leids Universitair Medisch Centrum
Leiden, 2333
Maastricht University Medical Centre
Maastricht, 6229 HX
Argentina2 sites
Hospital Universitario Austral
Buenos Aires, 1500
Instituto de Nefrología Trasplante Renal y Renopancreatico
Buenos Aires, 3889
Belgium2 sites
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
Centre Hospitalier - Universitaire de Liège
Liège, 4000
About this study
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
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).
Read the 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.
- Conditions
- Delayed Graft Function
- Being tested
- QPI-1002, Placebo
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QPI-1002Drug
IV injection
PlaceboOther
isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| QPI-1002 | Active comparator | QPI-1002 Injection, single dose Receives: Drug: QPI-1002 |
| Placebo | Placebo comparator | isotonic saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
Measured: Day 0 to Day 30
Secondary outcomes (2)
The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
Measured: 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.
Measured: Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Mar 2016
- Primary completion28 Jun 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quark Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Holman, M.D.,Ph.D., Study director, Quark Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610296
- Sponsor's protocol ID
- QRK306
- Acronym
- ReGIFT
- Status last verified
- May 2020
- First submitted
- 18 Nov 2015
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02610296
- Acronym / sponsor ID
- ReGIFT / QRK306
- Conditions
- Delayed Graft Function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 594 participants (actual)
- Lead sponsor
- Quark PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QPI-1002 | Active comparator | Drug: QPI-1002QPI-1002 Injection, single dose |
| Placebo | Placebo comparator | Other: Placeboisotonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QPI-1002IV injection | Drug | QPI-1002 |
| Placeboisotonic saline | Other | Placebo |
Primary outcome
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
2 secondary outcomes
The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
Time frame: 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.
Time frame: Day 0 to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Related trials for Delayed Graft Function
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
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The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Holman, M.D.,Ph.D. study director
Quark Pharmaceuticals
84 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QPI-1002 in people with Delayed Graft Function, run by Quark Pharmaceuticals at 84 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Spain, Germany, Brazil, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.