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

Delayed Graft Function Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610296
• Other study ID #: QRK306
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2016
• Est. completion date: January 8, 2019

Study information

• Verified date: May 2020
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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 information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: January 8, 2019
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Delayed Graft Function

Intervention

Drug:
• QPI-1002
IV injection

Other:
• Placebo
isotonic saline

Locations

Country	Name	City	State
Argentina	Hospital Universitario Austral	Buenos Aires
Argentina	Instituto de Nefrología Trasplante Renal y Renopancreatico	Buenos Aires
Australia	Royal Adelaide	Adelaide	South Australia
Australia	John Hunter Hospital	New Lambton	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	UZ Leuven - Campus Gasthuisberg	Leuven
Belgium	Centre Hospitalier - Universitaire de Liège	Liège 1
Brazil	Hospital Geral de Fortaleza	Fortaleza	CE
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)	Recife	PE
Brazil	Hospital São Francisco de Assis	Rio de Janeiro	RJ
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José do Rio Preto	SP
Brazil	Fundação Oswaldo Ramos - Hospital do Rim	São Paulo	SP
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	McGill University Health Centre	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Czechia	Klinika nefrologie IKEM	Praha 4
France	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
Germany	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	Hannover
Germany	University Hospital Schleswig Holstein, Campus Kiel	Kiel
Germany	Universitätsklinikum Tübingen	Tübingen
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Maastricht University Medical Centre	Maastricht
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d´Hebron	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Colorado, Denver	Aurora	Colorado
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Erie County Medical Center	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Baylor All Saints	Fort Worth	Texas
United States	University of Florida Health, Shands Hospital	Gainesville	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	St. Barnabas Medical Center	Livingston	New Jersey
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Columbia University	New York	New York
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	Integris Nazih Zuhdi Transplant Institute	Oklahoma City	Oklahoma
United States	Mayo Clinic Phoenix	Phoenix	Arizona
United States	Virginia Commonwealth University	Richmond	Virginia
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	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	SUNY Upstate NY University Hospital	Syracuse	New York
United States	Tampa General Hospital	Tampa	Florida
United States	Georgetown Transplant Institute	Washington	District of Columbia
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Quark Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  France,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.		Day 0 to Day 7
Secondary	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