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

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ClinicalTrials.gov Identifier: NCT02610296
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date May 13, 2020
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Delayed Graft Function
Intervention  ICMJE
  • Drug: QPI-1002
    IV injection
  • Other: Placebo
    isotonic saline
Study Arms  ICMJE
  • Active Comparator: QPI-1002
    QPI-1002 Injection, single dose
    Intervention: Drug: QPI-1002
  • Placebo Comparator: Placebo
    isotonic saline
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2018)
594
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
634
Actual Study Completion Date  ICMJE January 8, 2019
Actual Primary Completion Date June 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Netherlands,   Spain,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02610296
Other Study ID Numbers  ICMJE QRK306
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Holman, M.D.,Ph.D. Quark Pharmaceuticals
PRS Account Quark Pharmaceuticals
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP