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CompletedNCT02921789Updated Dec 4, 2024Results posted

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

A Phase 2 interventional study of Bleselumab and Basiliximab in Kidney Transplantation and Primary Focal Segmental Glomerulosclerosis (FSGS), sponsored by Astellas Pharma Global Development, Inc.. Completed at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was 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 were imputed as rFSGS.

Read the detailed description

The study consisted 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 entered into a Screening Period (Days -21 to -1 prior to transplant), and underwent a Transplant (Day 0 [zero]), and then followed for up to 12 months in the Post-Transplant Period (Day 0 through 12 months post-transplant).

02

Conditions studied

  • Kidney Transplantation
  • Primary Focal Segmental Glomerulosclerosis (FSGS)

Keywords

  • Bleselumab
  • ASKP1240
  • Efficacy and Safety
03

In context

Glomerulosclerosis, Focal Segmental

98 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 31 are open to participants now.

This study's enrollment of 67 is above the median of 32 across 69 interventional studies indexed under Glomerulosclerosis, Focal Segmental.

Browse Glomerulosclerosis, Focal Segmental studies →

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Active comparator
    Standard of Care (SOC) Regimen

    Participants received SOC regimen (basiliximab induction, MMF, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20 milligrams (mg) administered by intravenous injection prior to transplantation or intra- operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. MMF 1 gram (g) administered orally or intravenously twice daily until 12 months post transplant. Tacrolimus 0.1 milligram per kilogram per day (mg/kg/day) (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 nanogram per milliliter (ng/mL) administered orally within 48 hours post-transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

    Drug: Basiliximab · Drug: Mycophenolate Mofetil (MMF) · Drug: Tacrolimus Capsules · Drug: Methylprednisone · Drug: Prednisone

  • Experimental
    Bleselumab Regimen

    Participants received bleselumab regimen (basiliximab induction, bleselumab, Tacrolimus, Methylprednisone, Prednisolone). Basiliximab 20mg administered by intravenous injection prior to transplantation or intra - operatively before revascularisation as induction therapy and 20mg on day 3 or 4 or 5 post-transplant. Bleselumab 200mg administered by intravenous infusion on day 0, 7, 14, 28, 42, 56, 70, 90 and once per month until month 12. Tacrolimus 0.1 mg/kg/day (two equally divided doses at 0.05 mg/kg/day every 12 hours with a target trough level of 4 - 11 ng/mL) administered orally within 48 hours post transplant until 12 months post transplant. Methylprednisone 500, 250, 125 and 60mg administered orally or intravenously on days 0, 1, 2 and 3 respectively and continue through 12 months post transplant. Prednisolone administered orally by tapered doses of 20-30 mg on days 4-14, 10-20mg on days 15-28, 5-10mg on days 29 through 12 months post transplant.

    Drug: Bleselumab · Drug: Basiliximab · Drug: Tacrolimus Capsules · Drug: Methylprednisone · Drug: Prednisone

Interventions

  • DrugBleselumab

    Intravenous infusion

    Also known as: ASKP1240

  • DrugBasiliximab

    Bolus injection

    Also known as: Simulect®

  • DrugMycophenolate Mofetil (MMF)

    Oral Intravenous

    Also known as: CellCept®, MMF

  • DrugTacrolimus Capsules

    Oral Capsule

    Also known as: Prograf®

  • DrugMethylprednisone

    Oral or Intravenous

  • DrugPrednisone

    Oral Tablet

06

What researchers measure

Primary outcomes

  1. 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

    rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

    Time frame: At 3 Months post transplant

Secondary outcomes

  1. Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant

    rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

    Time frame: At 6 and 12 Months post transplant

  2. Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant

    All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria \>=1.

    Time frame: At 3, 6 and 12 Months post transplant

  3. Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant

    Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant.

    Time frame: 12 Months post transplant

  4. Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant

    Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist.

    Time frame: At 3, 6 and 12 Months post transplant

07

Results

Posted Jan 5, 2022

Participant flow

Participants were enrolled across multiple sites in Canada and USA. A total of 67 participants were randomized but 63 participants underwent a kidney transplant and received study drug.

Participant flow — Overall Study
MilestoneStandard of Care (SOC) RegimenBleselumab Regimen
Started3429
Randomized and took study drug3429
Completed2625
Not completed84
Withdrew: Adverse event01
Withdrew: Lost to follow-up10
Withdrew: Protocol deviation20
Withdrew: Withdrawal by subject21
Withdrew: Miscellaneous32

Outcome measures

PrimaryPercentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

Time frame:
At 3 Months post transplant
Reported as:
Number · Percentage of participants
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
Percentage of participantsSOC RegimenBleselumab Regimen
Percentage of Participants With Recurrence of Focal Segmental Glomerulosclerosis (rFSGS) or Death or Graft Loss or Lost to Follow-up Through 3 Months Post Transplant31.3 (16.1 to 50.0)18.5 (6.3 to 38.1)
Statistical analysis
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.3705 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -12.7 · 95% CI -34.5 to 9.0
SecondaryPercentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant

rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.

Time frame:
At 6 and 12 Months post transplant
Reported as:
Number · Percentage of participants
Percentage of Participants With rFSGS or Death or Graft Loss or Lost to Follow-up Through 6 and 12 Months Post Transplant
Percentage of participantsSOC RegimenBleselumab Regimen
Month 631.3 (16.1 to 50.0)18.5 (6.3 to 38.1)
Month 1235.5 (19.2 to 54.6)23.1 (9.0 to 43.6)
Statistical analysis
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.3705 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -12.7 · 95% CI -34.5 to 9.0
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.3890 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -12.4 · 95% CI -35.8 to 11.0
SecondaryPercentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant

All episodes of kidney dysfunction based on clinical signs and symptoms were evaluated for possible BPAR. BPAR was confirmed if participants Banff criteria \>=1.

Time frame:
At 3, 6 and 12 Months post transplant
Reported as:
Number · Percentage of participants
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Through 3, 6, and 12 Months Post Transplant
Percentage of participantsSOC RegimenBleselumab Regimen
Month 320.0 (7.7 to 38.6)26.9 (11.6 to 47.8)
Month 620.0 (7.7 to 38.6)26.9 (11.6 to 47.8)
Month 1224.1 (10.3 to 43.5)29.2 (12.6 to 51.1)
Statistical analysis
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.7520 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: 6.9 · 95% CI -15.3 to 29.2
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.7520 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: 6.9 · 95% CI -15.3 to 29.2
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.7597 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: 5.0 · 95% CI -18.9 to 29.0
SecondaryPercentage of Participants With Efficacy Failure Through 12 Months Post Transplant

Efficacy failure was defined as BPAR, death, graft loss or lost to follow-up through 12 months post transplant.

Time frame:
12 Months post transplant
Reported as:
Number · Percentage of participants
Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant
Percentage of participantsSOC RegimenBleselumab Regimen
Percentage of Participants With Efficacy Failure Through 12 Months Post Transplant32.3 (16.7 to 51.4)32.0 (14.9 to 53.5)
Statistical analysis
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 1.0 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -0.3 · 95% CI -24.9 to 24.3
SecondaryPercentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant

Percentage of participants with biopsy-proven rFSGS determined by a blinded central review of images from electron microscopy (EM) and slides for light microscopy (LM) by an independent pathologist.

Time frame:
At 3, 6 and 12 Months post transplant
Reported as:
Number · Percentage of participants
Percentage of Participants With Biopsy Proven rFSGS Through 3, 6 and 12 Months Post-Transplant
Percentage of participantsSOC RegimenBleselumab Regimen
Month 335.7 (18.6 to 55.9)31.8 (13.9 to 54.9)
Month 636.7 (19.9 to 56.1)30.4 (13.2 to 52.9)
Month 1236.7 (19.9 to 56.1)29.2 (12.6 to 51.1)
Statistical analysis
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 1.0 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -3.9 · 95% CI -30.2 to 22.4
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.7720 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -6.2 · 95% CI -31.7 to 19.3
  • SOC Regimen vs Bleselumab Regimen · Fisher Exact · p = 0.7720 (Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.) · Difference: -7.5 · 95% CI -32.6 to 17.6

Adverse events

Collected over Day of transplant through 12 months post transplant. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOC Regimen0/34 (0%)16/34 (47.1%)29/34 (85.3%)
Bleselumab Regimen0/29 (0%)16/29 (55.2%)28/29 (96.6%)
Most frequent serious events
Showing 10 of 63
Most frequent serious events
EventSOC RegimenBleselumab Regimen
Kidney transplant rejectionImmune system disorders5/341/29
Focal segmental glomerulosclerosisRenal and urinary disorders3/343/29
Acute kidney injuryRenal and urinary disorders3/342/29
HydronephrosisRenal and urinary disorders3/340/29
DehydrationMetabolism and nutrition disorders1/342/29
Cytomegalovirus infectionInfections and infestations2/340/29
Septic shockInfections and infestations2/340/29
UrosepsisInfections and infestations2/340/29
Iron deficiency anaemiaBlood and lymphatic system disorders0/341/29
MethaemoglobinaemiaBlood and lymphatic system disorders0/341/29
Most frequent other events
Showing 10 of 84
Most frequent other events
EventSOC RegimenBleselumab Regimen
Procedural painInjury, poisoning and procedural complications14/3410/29
DiarrhoeaGastrointestinal disorders11/348/29
NauseaGastrointestinal disorders11/346/29
TremorNervous system disorders11/348/29
HypomagnesaemiaMetabolism and nutrition disorders10/346/29
AnaemiaBlood and lymphatic system disorders9/348/29
VomitingGastrointestinal disorders9/344/29
HypophosphataemiaMetabolism and nutrition disorders9/346/29
HyperglycaemiaMetabolism and nutrition disorders8/344/29
ConstipationGastrointestinal disorders7/346/29

Baseline characteristics

Safety (SAF) population: All participants who were randomized and received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(Years)SOC RegimenBleselumab RegimenTotal
Mean39.9 ± 13.141.9 ± 15.240.5 ± 13.62
Sex: Female, Male
Sex: Female, Male(Participants)SOC RegimenBleselumab RegimenTotal
Female131124
Male211839
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SOC RegimenBleselumab RegimenTotal
Hispanic or Latino10515
Not Hispanic or Latino242448
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SOC RegimenBleselumab RegimenTotal
American Indian or Alaska Native000
Asian224
Native Hawaiian or Other Pacific Islander000
Black or African American6713
White202040
More than one race000
Unknown or Not Reported606
Number of Kidney Transplants
Number of Kidney Transplants(Participants)SOC RegimenBleselumab RegimenTotal
Number of kidney transplants = 1322759
Number of kidney transplants = 2224
08

Study locations

23 sites
  • University of Arizona
    Tucson, Arizona 85724, United States
  • Stanford School of Medicine
    Palo Alto, California 94304, United States
  • UCSF
    San Francisco, California 94143, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • University of Miami
    Miami, Florida 33136, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Indiana University
    Indianapolis, Indiana 46220, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Tulane University Health Service Center
    New Orleans, Louisiana 70112, United States
  • Michigan Medicine
    Ann Arbor, Michigan 48109, United States
  • Washington University in St. Louis
    Saint Louis, Missouri 63110, United States
  • St. Barnabas
    Livingston, New Jersey 07039, United States
  • Erie County Medical Center
    Buffalo, New York 14215, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27713, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • University of Pennsylvania Health System, PCAM
    Philadelphia, Pennsylvania 19104, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • University of Utah Medical Center
    Salt Lake City, Utah 84132, United States
  • University of Virginia
    Charlottesville, Virginia 22908, United States
  • Site CA15002
    Edmonton, Alberta TG6 2B7, Canada
  • Site CA15005
    Vancouver, British Columbia V6Z 1Y6, Canada
  • Site CA15006
    Montreal, Quebec H1T 2M4, Canada
09

References and documents

Study documents

  • Study protocol · Feb 2, 2018
  • Statistical analysis plan · Nov 20, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02921789
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Oct 3, 2016
Start date
May 22, 2017
Primary completion
Dec 11, 2020
Completion
May 18, 2021
Results posted
Jan 5, 2022
Last update
Dec 4, 2024

Study contacts

Medical Director
study director · Astellas Pharma Global Development, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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