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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02921789
Date of registration: 30/09/2016
Prospective Registration: Yes
Primary sponsor: Astellas Pharma Global Development, Inc.
Public title: Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
Scientific title: 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
Date of first enrolment: May 22, 2017
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02921789
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Canada United States
Contacts
Name:     Astellas Pharma Global Development - US
Address: 
Telephone: 800-888-7704
Email: astellas.registration@astellas.com
Affiliation: 
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Astellas Pharma Global Development, Inc.
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Focal Segmental Glomerulosclerosis (FSGS)
Kidney Transplantation
Intervention(s)
Drug: Basiliximab
Drug: Bleselumab
Drug: Methylprednisone
Drug: Mycophenolate Mofetil (MMF)
Drug: Prednisone
Drug: Tacrolimus Capsules
Primary Outcome(s)
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]
Secondary Outcome(s)
Biopsy-proven (blinded, central read) rFSGS [Time Frame: Up to 12 months post-transplant]
Biopsy-proven acute rejection (BPAR) (Banff Grade = 1, local read) [Time Frame: Up to 12 months post-transplant]
Efficacy failure [Time Frame: Up to 12 months post-transplant]
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]
Secondary ID(s)
7163-CL-3201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Kyowa Kirin Co., Ltd.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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