Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2022
• 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: 67
• Recruitment status: Completed
• 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: Medical Director
• 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

Kidney Transplantation

Primary Focal Segmental Glomerulosclerosis (FSGS)

Intervention(s)

Drug: Mycophenolate Mofetil (MMF)

Drug: Basiliximab

Drug: Prednisone

Drug: Methylprednisone

Drug: Tacrolimus Capsules

Drug: Bleselumab

Primary Outcome(s)

Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant [Time Frame: At 3 Months post transplant]

Secondary Outcome(s)

Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant [Time Frame: At 6 and 12 Months post transplant]

Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant [Time Frame: At 3, 6 and 12 Months post transplant]

Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant [Time Frame: At 3, 6 and 12 Months post transplant]

Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant [Time Frame: 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.

Results

• Results available: Yes
• Date Posted: 05/01/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02921789