Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT02490202|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Delayed Function of Renal Transplant||Drug: SANGUINATE Drug: Normal Saline||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||October 2016|
Two (2) infusions of SANGUINATE
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Other Name: pegylated carboxyhemoglobin bovine
Placebo Comparator: Normal Saline
Two (2) infusions of Normal Saline
Drug: Normal Saline
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
- 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
- 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 ]
- Determination of sample size for Phase 3 based upon the results from Phase 2. [ Time Frame: 30 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490202
|Study Director:||Hemant Misra, PhD||Prolong Pharmaceuticals|