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NCT03663335 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 418
- Enrollment target
NCT03663335: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03663335 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 418 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (214% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663335, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 418 participants
- Enrollment target
Study Summary
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Primary Outcome
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day o
Interventions
- DRUG Tacrolimus
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Corticosteroids (CS)
- BIOLOGICAL CFZ533 - Cohort 1/Cohort 2
- DRUG Induction therapy: basiliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2021-10-29 |
| Phase | Phase 2 |
What the finished NCT03663335 record still lists
NCT03663335 is an interventional study that assigns participants to a tested intervention. The registered 418 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 (214% higher).
The record links to 0 conditions, and to 5 interventions - of which Tacrolimus is the first listed.
NCT03663335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03663335 about?
NCT03663335 is a clinical study titled "Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients". This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
What is the current status of trial NCT03663335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 418 participants. The study started on 2018-11-28. Estimated completion is 2021-10-29.
What interventions are being tested in trial NCT03663335?
The interventions under investigation include: Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Corticosteroids (CS) (DRUG), CFZ533 - Cohort 1/Cohort 2 (BIOLOGICAL), Induction therapy: basiliximab (DRUG).
Who is sponsoring clinical trial NCT03663335?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03663335's enrollment target sits among peer trials
418 91st of 2000 higher than 1,910 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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