Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 149 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01780844
The ClinicalTrials.gov registry entry for NCT01780844 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus is the first listed.
NCT01780844 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.