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NCT01780844 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT01780844: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT01780844 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01780844, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Tacrolimus
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Basiliximab
- DRUG Methylprednisone
- DRUG ASKP1240
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2013-03-05 |
| Est. Completion | 2017-01-27 |
| Phase | Phase 2 |
What the finished NCT01780844 record still lists
NCT01780844 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus is the first listed.
NCT01780844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01780844 about?
NCT01780844 is a clinical study titled "A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients". 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 \[ca...
What is the current status of trial NCT01780844?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2013-03-05. Estimated completion is 2017-01-27.
What interventions are being tested in trial NCT01780844?
The interventions under investigation include: Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Basiliximab (DRUG), Methylprednisone (DRUG), ASKP1240 (DRUG).
Who is sponsoring clinical trial NCT01780844?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01780844's enrollment target sits among peer trials
149 491st of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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