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Trial record 1 of 1 for:    ASKP1240 NCT02921789
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Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02921789
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 3, 2016
Last Update Posted Date January 30, 2020
Actual Study Start Date  ICMJE May 22, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
Recurrence of focal segmental glomerulosclerosis (FSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Deaths, graft loss and lost to follow-up will be imputed as rFSGS. [ Time Frame: Up to 3 months post-transplant ]
All episodes of kidney dysfunction based on clinical signs and symptoms will be evaluated by a biopsy at the local pathological laboratory for recurrence of FSGS and for possible rejection. The same slides and images of the biopsy will also be sent to a central pathology lab and read by an independent pathologist to determine recurrence of FSGS.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
Recurrence of focal segmental glomerulosclerosis (FSGS) as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology through 3 months post-transplant [ Time Frame: Up to 3 months post-transplant ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
  • Recurrence of FSGS defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g). Deaths, graft loss and lost to follow-up will be imputed as rFSGS. [ Time Frame: Up to 12 months post-transplant ]
    All episodes of kidney dysfunction based on clinical signs and symptoms will be evaluated by a biopsy at the local pathological laboratory for recurrence of FSGS and for possible rejection. The same slides and images of the biopsy will also be sent to a central pathology lab and read by an independent pathologist to determine recurrence of FSGS.
  • Biopsy-proven acute rejection (BPAR) (Banff Grade ≥ 1, local read) [ Time Frame: Up to 12 months post-transplant ]
    All episodes of kidney dysfunction based on clinical signs and symptoms will be evaluated for possible rejection. All subjects should have biopsy confirmation of rejection before treatment is begun or within 48 hours of initiation of treatment for acute rejection. The pathologist at the clinical site will grade all biopsies using the 2007 Banff criteria (Grading of Acute Kidney Allograft Rejection). Biopsy-proven acute rejection (BPAR, T- or B-cell) will be determined by local review.
  • Efficacy failure [ Time Frame: Up to 12 months post-transplant ]
    Efficacy failure defined as BPAR (Banff Grade ≥ 1; local read), death, graft loss, or lost to follow-up
  • Biopsy-proven (blinded, central read) rFSGS [ Time Frame: Up to 12 months post-transplant ]
    Biopsy-proven rFSGS will include only those for whom slides are reviewed by the independent pathologist who will be the blinded, central reader. All subjects are required to provide a biopsy either after the appearance of symptoms for rejection or rFSGS, or at the day 90/month 3 visit, if there has not been a previous biopsy indicating rFSGS in the transplanted kidney. The blinded, central reader will objectively assess podocyte changes to identify those with rFSGS.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2016)
  • Recurrence of FSGS as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology [ Time Frame: Up to 12 months post-transplant ]
  • Biopsy-proven recurrence (blinded, central read) of FSGS in transplanted kidney [ Time Frame: Up to 12 months post-transplant ]
  • Biopsy provide acute rejection (BPAR) (Banff Grade ≥ 1, local read) [ Time Frame: Up to 12 months post-transplant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS.
Detailed Description The study will consist of the following periods: Screening (Days -21 to -1), Transplant (Day 0), Post-Transplant (Day 0/post-skin closure through 12 months post-transplant). All subjects will enter into a Screening Period (Days -21 to -1 prior to transplant), undergo a Transplant (Day 0 [zero]), and are then to be followed for up to 12 months in the Post-Transplant Period (Day 0 through 12 months post-transplant).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Transplantation
  • Focal Segmental Glomerulosclerosis (FSGS)
Intervention  ICMJE
  • Drug: Bleselumab
    Intravenous infusion
    Other Name: ASKP1240
  • Drug: Basiliximab
    Bolus injections
    Other Name: Simulect®
  • Drug: Mycophenolate Mofetil (MMF)
    Oral (po) or intravenous (iv) two times a day (bid)
    Other Names:
    • CellCept®
    • MMF
  • Drug: Tacrolimus Capsules
    Oral (po) or intravenous (iv) if medically indicated
    Other Name: Prograf®
  • Drug: Methylprednisone
    Oral (po) or intravenous (iv)
  • Drug: Prednisone
    Oral (po)
Study Arms  ICMJE
  • Active Comparator: Standard of Care Regimen
    Standard of Care regimen (basiliximab induction, tacrolimus, methylprednisone, prednisone and MMF).
    Interventions:
    • Drug: Basiliximab
    • Drug: Mycophenolate Mofetil (MMF)
    • Drug: Tacrolimus Capsules
    • Drug: Methylprednisone
    • Drug: Prednisone
  • Experimental: Bleselumab Regimen
    Bleselumab regimen (basiliximab, methylprednisone, prednisone, bleselumab and tacrolimus).
    Interventions:
    • Drug: Bleselumab
    • Drug: Basiliximab
    • Drug: Tacrolimus Capsules
    • Drug: Methylprednisone
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a recipient of a de novo kidney from a living or deceased donor and has biopsy-proven, primary FSGS (pFSGS) as a cause of end stage renal disease (ESRD) in the subject's native kidneys (initial diagnosing biopsy report is required). A subject who has biopsy-proven pFSGS as a cause of ESRD, and the subject's most current graft failure(s) is due to the recurrence of FSGS, is eligible.
  • Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure.
  • Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
  • Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

  • Subject has Induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen.
  • Subject has a diagnosis of secondary FSGS (familial, virus associated, medication, etc.) or a defined genetic cause of FSGS.
  • 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.
  • Subject will receive a kidney as part of a multi-organ transplant.
  • Subject will receive a dual kidney transplant from a deceased donor.
  • Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours.
  • Subject will receive a kidney that meets BOTH Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. (A kidney that meets either ECD OR DCD criteria may be eligible for inclusion.)
  • Subject will receive a blood group system (A, AB, B, O, ABO) incompatible (including A2 into B or O) donor kidney.
  • Recipient or donor is known to be seropositive for human immuno-deficiency virus (HIV).
  • Subject has a current calculated panel reactive antibody (cPRA) level > 50%.
  • Subject has a current malignancy or a history of malignancy (within the past 5 years), except nonmetastatic 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.
  • Subject has significant liver disease, defined as having during the past 21 days consistently elevated aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) levels greater than 1.5 times the upper value of the normal range of the investigational site.
  • 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.
  • Subject has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  • Subject is concurrently participating in another drug study or has received an investigational drug up to 30 days or 5 half-lives prior to transplant.
  • Subject is currently receiving or has received up to 8 weeks prior to transplant an immunologic biologic compound (i.e., tumor necrosis factor (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.
  • Subject has previously received bleselumab or participated in a clinical study with bleselumab.
  • Subject has a known hypersensitivity to tacrolimus, MMF, basiliximab, corticosteroids, or any of the components.
  • Subject has any form of substance abuse, psychiatric disorder, or a condition that could invalidate communication with the Investigator.
  • Subject has a clinically significant abnormal electrocardiogram (ECG) at Screening.
  • Subject is unlikely to comply with the visits scheduled in the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Astellas Pharma Global Development - US 800-888-7704 astellas.registration@astellas.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02921789
Other Study ID Numbers  ICMJE 7163-CL-3201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Kyowa Kirin Co., Ltd.
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP