Delayed Function of Renal TransplantPhase 2/3NCT02490202
Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant
A Phase 2/3 study testing SANGUINATE and Normal Saline in people with Delayed Function of Renal Transplant, run by Prolong Pharmaceuticals at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Function of Renal Transplant
- What is being tested?
- SANGUINATE and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 20 sitesUnited States
- Study dates
- Aug 2015to Oct 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- Body Mass Index (BMI) > 38 kg/m2
- 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)
- History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator
- Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability
- History or presence of any disease or psychiatric condition that in the Investigator's assessment that would increase the risk to subjects associated with study participation, drug administration or interpretation of results
- History of biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ skin lesions, carcinoma of the cervix in situ, or early detected prostate cancer.
- Female subject who is pregnant or breast feeding.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Augusta University
Augusta, Georgia, 30912
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
UIC University of Illinois at Chicago
Chicago, Illinois, 60612
The Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48212
Central Pennsylvania Transplant Foundation
Harrisburg, Pennsylvania, 17104
Houston Methodist Hospital
Houston, Texas, 77030
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
University of California, Los Angeles
Los Angeles, California, 90024
University of Wisconsin
Madison, Wisconsin, 53706
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
California Institute of Renal Research
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco
San Francisco, California, 94143
Tampa General Hospital
Tampa, Florida, 33606
University of Toledo
Toledo, Ohio, 43537
Medstar Georgetown University Hosiptal
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Placebo-controlled, Prospective, Double-blind, Multicenter Phase 2/3 Study of the Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Recipients of a Donation After Brain Death Kidney Transplant
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.
Read the detailed description
Phase 2: Sixty (60) adult subjects who will be recipients of a donation after brain death (DBD) donor kidney and who meet all eligibility criteria will be randomized 1:1 within 48 hours prior to transplant surgery to receive: two infusions of SANGUINATE at a dose of 320 mg/kg or placebo on the day of surgery and approximately 24 hours after surgery. Patients will be hospitalized for up to 5 days and the study duration will be 30 days. Results will be used to inform the study design characteristics for Phase III, including sample size.
Phase III: The same inclusion/exclusion requirements, dosing schedule, hospitalization stay and outpatient visits as in Phase II with additional visits scheduled at Day 90, Day 180 and Day 365. Study duration will be 365 days.
- Conditions
- Delayed Function of Renal Transplant
- Being tested
- SANGUINATE, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANGUINATEDrug
Also called pegylated carboxyhemoglobin bovine
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Normal SalineDrug
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
| Study group | Role | What they receive |
|---|---|---|
| SANGUINATE | Experimental | Two (2) infusions of SANGUINATE Receives: Drug: SANGUINATE |
| Normal Saline | Placebo comparator | Two (2) infusions of Normal Saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of delayed graft function (DGF)
Reduction of delayed draft function will be measured by the number of dialysis sessions.
Measured: 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
Measured: Phase 2 - 30 Days; Phase 3: Safety - 90 days; Serious Adverse Events and Adverse Events of Special Interest - 180 Days; Graft Survival - 365 Days
Secondary outcomes (6)
Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
Measured: 7 Days
Proportion of subjects requiring dialysis only in the first 5 days post-transplant
Measured: 5 Days
Number of days of dialysis therapy.
Measured: 30 Days
Proportion of subjects with a fall in serum creatinine.
Measured: 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
Measured: 5 Days
Rate of change in estimated creatinine clearance and estimated glomerular filtration rate over time
Measured: Phase 2: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Function of Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolong Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hemant Misra, PhD, Study director, Prolong Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490202
- Sponsor's protocol ID
- SGTP-002
- Status last verified
- Oct 2016
- First submitted
- 16 Jun 2015
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Prospective, Double-blind, Multicenter Phase 2/3 Study of the Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Recipients of a Donation After Brain Death Kidney Transplant
- ClinicalTrials.gov ID
- NCT02490202
- Acronym / sponsor ID
- SGTP-002
- Conditions
- Delayed Function of Renal Transplant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prolong PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 2: Sixty (60) adult subjects who will be recipients of a donation after brain death (DBD) donor kidney and who meet all eligibility criteria will be randomized 1:1 within 48 hours prior to transplant surgery to receive: two infusions of SANGUINATE at a dose of 320 mg/kg or placebo on the day of surgery and approximately 24 hours after surgery. Patients will be hospitalized for up to 5 days and the study duration will be 30 days. Results will be used to inform the study design characteristics for Phase III, including sample size.
Phase III: The same inclusion/exclusion requirements, dosing schedule, hospitalization stay and outpatient visits as in Phase II with additional visits scheduled at Day 90, Day 180 and Day 365. Study duration will be 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SANGUINATE | Experimental | Drug: SANGUINATETwo (2) infusions of SANGUINATE |
| Normal Saline | Placebo comparator | Drug: Normal SalineTwo (2) infusions of Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SANGUINATEAlso: pegylated carboxyhemoglobin bovineTwo (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1 | Drug | SANGUINATE |
| Normal SalineTwo (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1. | Drug | Normal Saline |
Primary outcome
Reduction of delayed graft function (DGF)
Time frame: 30 Days
Reduction of delayed draft function will be measured by the number of dialysis sessions.
Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group
Time frame: Phase 2 - 30 Days; Phase 3: Safety - 90 days; Serious Adverse Events and Adverse Events of Special Interest - 180 Days; Graft Survival - 365 Days
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events
6 secondary outcomes
Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
Time frame: 7 Days
Proportion of subjects requiring dialysis only in the first 5 days post-transplant
Time frame: 5 Days
Number of days of dialysis therapy.
Time frame: 30 Days
Proportion of subjects with a fall in serum creatinine.
Time frame: 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
Time frame: 5 Days
Rate of change in estimated creatinine clearance and estimated glomerular filtration rate over time
Time frame: Phase 2: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hemant Misra, PhD study director
Prolong Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SANGUINATE and Normal Saline in people with Delayed Function of Renal Transplant, run by Prolong Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of delayed graft function (DGF) (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.