Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT02921789. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02921789
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 67 participants
Conditions and interventions
Interventions
- Bleselumab Drug
- Basiliximab Drug
- Mycophenolate Mofetil (MMF) Drug
- Tacrolimus Capsules Drug
- Methylprednisone Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 22, 2017 (Actual)
- Primary completion
- Dec 11, 2020 (Actual)
- Completion
- May 18, 2021 (Actual)
- Last update posted
- Dec 4, 2024
2017 – 2021
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | — |
| Stanford School of Medicine | Palo Alto | California | 94304 | — |
| UCSF | San Francisco | California | 94143 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| University of Miami | Miami | Florida | 33136 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46220 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane University Health Service Center | New Orleans | Louisiana | 70112 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| St. Barnabas | Livingston | New Jersey | 07039 | — |
| Erie County Medical Center | Buffalo | New York | 14215 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27713 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Pennsylvania Health System, PCAM | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02921789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2024 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02921789 live on ClinicalTrials.gov.