A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de novo Kidney Transplant Recipients

Primary Objective

Primary Objective: - To assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the SOC regimen (basiliximab induction, tacrolimus, steroids and MMF) in the prevention of the recurrence of focal segmental glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with proteincreatinine ratio (> or equal to 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. Secondary Objectives: - To assess the incidence of nephrotic range proteinuria with protein-creatinine ratio (> or equal to 3.0 g/g) through 6 and 12 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS. - To assess the incidence of biopsy-proven acute rejection (BPAR, Banff Grade ≥ 1; local read) through 3, 6 and 12 months post-transplant. - To assess the incidence of efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss or lost to follow-up through 12 months post-transplant. - To assess the incidence of biopsy-proven (blinded, central read) rFSGS through 3, 6 and 12 months post-transplant. - To assess the safety of the bleselumab regimen compared with the SOC regimen.

This Study is
No Longer Enrolling

Description

This is a Phase 2a, randomized, open-label, active control, multi-center study to assess the efficacy and safety of bleselumab in preventing the rFSGS in de novo kidney transplant subjects.

Details
Age

Adult

Eligibility

Inclusion Criteria: 1. Male or female subject must be ≥ 18 years of age. 2. Subject is a recipient of a de novo kidney from a living or deceased donor and has biopsy proven, pFSGS as a cause of ESRD in their native kidneys (initial diagnosing biopsy report is required). A subject who has biopsy-proven pFSGS as a cause of ESRD, and their most current graft failure(s) is due to biopsy-proven, recurrent FSGS, is eligible. 3. Female subjects of childbearing potential must agree not to try to become pregnant during the study and for 90 days post-last dose, and have a negative serum pregnancy test at screening, and, if heterosexually active, agree to consistently use two forms of highly-effective birth control* (at least one of which must be a barrier method) starting at screening, throughout the study and for 90 days post-last dose. 4. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective form of contraception consisting of two forms of birth control starting at screening, throughout the study and for 90 days post-last dose. Exclusion Criteria: 1. Subject has Induction therapy, other than study-assigned basiliximab 2. Subjects with a diagnosis of secondary FSGS (familial, virus associated, medication, etc.) or a defined genetic cause of FSGS. 3. Subject has previously received any organ transplant including a kidney and the most current graft failure(s) is not due to the recurrence of FSGS. 4. Subject will receive a kidney as part of a multi-organ transplant, or a dual kidney transplant from a deceased donor, or a kidney with an anticipated cold ischemia time of > 30 hours, or a kidney that meets BOTH Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. 5. Subject will receive a blood group system (A, AB, B, O, ABO) incompatible (including A2 into B or O) donor kidney. 6. Recipient or donor is known to be seropositive for human immuno-deficiency virus (HIV). 7. Subject has a current calculated panel reactive antibody (cPRA) level > 50%. 8. Subject has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully, or a renal cell carcinoma that has been treated successfully more than 2 years prior to transplantation. 9. Subject has significant liver disease, defined as having during the past 21 days 10. Subject is known to have a positive test for latent tuberculosis (TB) and has not previously received adequate anti-microbial therapy/or would require TB prophylaxis after transplant. 11. Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. 12. Subject is concurrently participating in another drug study or has received an investigational drug up to 30 days or 5 half-lives (depending on medication) prior to transplant. 13. Subject is currently receiving or has received up to 8 weeks prior to transplant an immunologic biologic compound (i.e., TNF inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin [IVIG]). A subject who has previously received a kidney organ transplant and is currently on an immunosuppression regimen that includes MMF, or any of its components, must discontinue MMF. 14. Subject has previously received bleselumab or participated in a clinical study with bleselumab. 15. Subject has a known hypersensitivity to tacrolimus, basiliximab, MMF, corticosteroids, or any of their components. 16. Subject has any form of substance abuse, psychiatric disorder, or a condition that in the opinion of the Investigator could invalidate communication with the Investigator. 17. Subject has a clinically significant abnormal ECG at screening.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Scope

National

Locations

University of Colorado Hospital

Study ID

Protocol Number: 17-1010

More information available at ClinicalTrials.gov: NCT02921789

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