A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT01780844. 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 ASKP1240 in de Novo Kidney Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids \[calcineurin inhibitor (CNI) avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids \[CNI minimization-MMF avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
Study identification
- NCT ID
- NCT01780844
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 149 participants
Conditions and interventions
Conditions
Interventions
- ASKP1240 Drug
- Tacrolimus Drug
- Mycophenolate Mofetil (MMF) Drug
- Basiliximab 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
- Mar 5, 2013 (Actual)
- Primary completion
- Jun 30, 2014 (Actual)
- Completion
- Jan 27, 2017 (Actual)
- Last update posted
- Nov 21, 2025
2013 – 2017
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site US10006 | Birmingham | Alabama | 35233 | — |
| Site US10024 | Phoenix | Arizona | 85054 | — |
| Site US10008 | Los Angeles | California | 90057 | — |
| Site US10021 | Palo Alto | California | 94304 | — |
| Site US10030 | San Diego | California | 92123 | — |
| Site US10004 | San Francisco | California | 94115 | — |
| Site US10003 | San Francisco | California | 94143 | — |
| Site US10013 | Aurora | Colorado | 80045 | — |
| Site US10007 | Atlanta | Georgia | 30322 | — |
| Site US10041 | Augusta | Georgia | 30912 | — |
| Site US10010 | Chicago | Illinois | 60612 | — |
| Site US10018 | Chicago | Illinois | 60612 | — |
| Site US10037 | Chicago | Illinois | 60637 | — |
| Site US10015 | Lexington | Kentucky | 40536 | — |
| Site US10045 | New Orleans | Louisiana | 70112 | — |
| Site US10014 | Baltimore | Maryland | 21201 | — |
| Site US10017 | Ann Arbor | Michigan | 48109 | — |
| Site US10025 | St Louis | Missouri | 63110 | — |
| Site US10022 | Livingston | New Jersey | 07039 | — |
| Site US10031 | Buffalo | New York | 14215 | — |
| Site US10034 | New York | New York | 10029 | — |
| Site US10023 | New York | New York | 10065 | — |
| Site US10019 | The Bronx | New York | 10467 | — |
| Site US10036 | Chapel Hill | North Carolina | 27599 | — |
| Site US10042 | Charlotte | North Carolina | 28203 | — |
| Site US10016 | Durham | North Carolina | 27710 | — |
| Site US10026 | Greenville | North Carolina | 27834 | — |
| Site US10009 | Cincinnati | Ohio | 45267 | — |
| Site US10040 | Cleveland | Ohio | 44106 | — |
| Site US10032 | Cleveland | Ohio | 44195 | — |
| Site US10027 | Harrisburg | Pennsylvania | 17011 | — |
| Site US10038 | Pittsburgh | Pennsylvania | 15213 | — |
| Site US10012 | Charleston | South Carolina | 29425 | — |
| Site US10028 | Memphis | Tennessee | 38104 | — |
| Site US10035 | Nashville | Tennessee | 37232-4750 | — |
| Site US10001 | Dallas | Texas | 75246 | — |
| Site US10002 | Fort Worth | Texas | 76104 | — |
| Site US10029 | Houston | Texas | 77030 | — |
| Site US10044 | Houston | Texas | 77030 | — |
| Site US10033 | Salt Lake City | Utah | 84132 | — |
| Site US10020 | Charlottesville | Virginia | 22908 | — |
| Site US10005 | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01780844, 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 Nov 21, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01780844 live on ClinicalTrials.gov.