Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 15-004525
NCT ID: NCT02490202
Sponsor Protocol Number: SGTP-002
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- 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.
- 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
- 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 a 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
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Raymond Heilman, M.D.
Closed for enrollment