Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney

Study Overview
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Brief Summary
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The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.

Official Title
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A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney

Conditions
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Delayed Graft Function

Intervention / Treatment
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* Drug: ANG-3777
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits. Males and females ≥ 18 years of age. Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation. Patient is to be the recipient of a first kidney transplant from a deceased donor. Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney. Body mass index < 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used.. Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours). Exclusion Criteria Scheduled for multiple organ transplantation or prior recipient of a transplanted organ. Recipient of an ABO-incompatible kidney. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc. Recipient of a kidney preserved by normothermic pulsatile machine perfusion. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation. Concurrent sepsis or active bacterial infection. Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BB3<br>Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row | Drug: ANG-3777<br> <br> * Other names: BB3;|
| Placebo Comparator: Normal Saline<br>Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row | Other: Placebo<br> <br> * Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of DGF | The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12. | Day 360 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DGF, Delayed Graft Function, Renal Transplantation, Deceased Donor Kidney, BB3, Kidney Transplantation, Acute Kidney Injury