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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03510897




Registration number
NCT03510897
Ethics application status
Date submitted
18/04/2018
Date registered
27/04/2018
Date last updated
7/08/2019

Titles & IDs
Public title
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Scientific title
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Secondary ID [1] 0 0
QRK309
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 0 0
Condition category
Condition code

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

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

Placebo Comparator: Placebo - isotonic saline


Treatment: Drugs: QPI-1002
IV injection

Treatment: Drugs: Placebo
isotonic saline

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects through day 90 who develop major adverse kidney events
Timepoint [1] 0 0
Baseline through day 90
Secondary outcome [1] 0 0
Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery
Timepoint [1] 0 0
Baseline through day 5
Secondary outcome [2] 0 0
Renal function as estimated by glomerular filtration rate
Timepoint [2] 0 0
Baseline through Day 90
Secondary outcome [3] 0 0
Proportion of subjects who die or initiate dialysis through day 90
Timepoint [3] 0 0
Baseline through day 90

Eligibility
Key inclusion criteria
Key

- Male or female, age = 18 years old

- At risk for AKI following cardiac surgery on the basis of at least one of the
following pre-operatively assessed risk factors:

- Reduced renal function

- Diabetes with ongoing insulin treatment

- Albuminuria

- Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of
cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Emergent surgeries, including aortic dissection, and major congenital heart defects

- Undergoes cardiac surgery off CPB for subjects =45 years old. (Cardiac surgery off CPB
for subjects <45 years old is allowed.)

- Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is
inserted or anticipated

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QeenslandQLD,SA,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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District of Columbia
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Georgia
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New York
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Oregon
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Pennsylvania
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Utah
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Leuven
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Ontario
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Hradec Králové
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Czechia
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Praha 4
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France
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Besançon
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France
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Pessac Cedex
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France
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Reims
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France
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Rennes
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Germany
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Bavaria
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Brandenburg
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Deutschland
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Hesse
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Saxony
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Bad Krozingen
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Bad Neustadt An Der Saale
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Berlin
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Bonn
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Dresden
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Essen
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Heidelberg
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Lubeck
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Mainz
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München
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Auckland
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Hamilton
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Wellington
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Barcelona
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Cordoba
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Navarra
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Barakaldo
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Madrid
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Oviedo
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Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major
Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following
cardiac surgery. Half of the participants will receive QPI-1002 while the other half will
receive placebo.
Trial website
https://clinicaltrials.gov/show/NCT03510897
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Holman, MD.,PhD.
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
Quark Pharma Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
510-402-4020
Fax 0 0
Email 0 0
ClinicalTrials@quarkpharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03510897