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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02610296




Registration number
NCT02610296
Ethics application status
Date submitted
18/11/2015
Date registered
20/11/2015
Date last updated
13/05/2020

Titles & IDs
Public title
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
Scientific 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
Secondary ID [1] 0 0
QRK306
Universal Trial Number (UTN)
Trial acronym
ReGIFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Graft Function 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QPI-1002
Other interventions - Placebo

Active Comparator: QPI-1002 - QPI-1002 Injection, single dose

Placebo Comparator: Placebo - isotonic saline


Treatment: Drugs: QPI-1002
IV injection

Other interventions: Placebo
isotonic saline
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
Timepoint [1] 0 0
Day 0 to Day 30
Secondary outcome [1] 0 0
The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.
Timepoint [1] 0 0
Day 0 to Day 7
Secondary outcome [2] 0 0
The proportion of subjects with a decrease in serum creatinine of = 10% on three consecutive days in the first 7 days post-transplant.
Timepoint [2] 0 0
Day 0 to Day 7

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/01/2019
Sample size
Target
Accrual to date
Final
594
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Royal Adelaide - Adelaide
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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CE
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Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Quark Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02610296
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Holman, M.D.,Ph.D.
Address 0 0
Quark Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02610296