A Study on SANGUINATE™ for the Reduction of Delayed Graft Function in Kidney Transplant Patients
A Randomized, Placebo-controlled, Prospective, Single-blind, Single Center Phase 2 Study of the Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Recipients of a Donation After Brain Death Kidney Transplant
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2016
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 25, 2018
May 1, 2018
2.7 years
January 12, 2016
May 23, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of delayed graft function (DGF)
Reduction of delayed draft function will be measured by the number of dialysis sessions.
30 Days
Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group.
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events and Graft Survival - 30 Days
30 Days
Secondary Outcomes (7)
Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
7 Days
Proportion of subjects requiring dialysis only in the first 5 days post-transplant
5 Days
Number of days of dialysis therapy.
30 Days
Proportion of subjects with a fall in serum creatinine.
7 Days
Proportion of subjects with a serum creatinine greater than 3 mg/dL, but who did not require dialysis by Day 5 post-transplant
5 Days
- +2 more secondary outcomes
Study Arms (2)
SANGUINATE
EXPERIMENTALTwo (2) infusions of SANGUINATE
Normal Saline
PLACEBO COMPARATORTwo (2) infusions of Normal Saline
Interventions
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
Eligibility Criteria
You may qualify if:
- Able to understand and provide written informed consent.
- Male or female subject at least 18 years of age.
- Dialysis-dependent renal failure initiated at least 3 months prior to transplantation.
- Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria).
- Is able to receive intravenous infusions of study drug.
- Anticipated donor organ cold ischemia time \< 30 hours.
- A calculated prediction of DGF risk of least 25%.
- Females of childbearing potential must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period.
- Male subjects must agree to use condoms or other suitable means of pregnancy prevention.
You may not qualify if:
- Has received a blood transfusion of packed red blood cells (PRBC), other than with leukocyte-poor blood, within the 90-day period prior to screening.
- 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.
- Is scheduled to undergo multi-organ transplantation.
- Has planned transplant of kidney(s) from a donor \< 6 years of age.
- Has 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.
- Body Mass Index (BMI) \> 38 kg/m2
- Machine perfused preservation donor kidney.
- Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another Investigational New Drug) for ischemic/reperfusion injury immediately prior to organ recovery.
- Is scheduled to receive an blood type-incompatible donor kidney.
- Has undergone desensitization to remove antibodies prior to transplantation.
- Total bilirubin \> 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency
- 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. Potential subjects participating in a strictly observational study or a study involving approved treatments should be discussed with the Medical Monitor.
- Has a history of human immunodeficiency virus (HIV)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hemant Misra, PhD
Prolong Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 18, 2016
Study Start
February 1, 2016
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
May 25, 2018
Record last verified: 2018-05