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NCT02217410 · ClinicalTrials.gov registry record · Phase 1
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
A Phase 1 study of Kidney Transplantation, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 14
- Study locations
NCT02217410: Completed Phase 1 study of Kidney Transplantation, sponsored by Novartis Pharmaceuticals.
NCT02217410 is a Phase 1 study of Kidney Transplantation that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (78% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02217410, a Phase 1 study of Kidney Transplantation, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.
Primary Outcome
Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I
Conditions Studied
Interventions
- DRUG Tacrolimus (Tac)
- DRUG Mycophenolate mofetil (MMF)
- BIOLOGICAL CFZ533
- DRUG Corticosteroids (CS)
- BIOLOGICAL anti-IL2 Induction
Study Locations (14)
Other
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Hamburg
- Novartis Investigative Site - Heidelberg
- Novartis Investigative Site - Groningen
- Novartis Investigative Site - Rotterdam
Michigan
- Novartis Investigative Site - Ann Arbor
- Novartis Investigative Site - Detroit
Colorado
- Novartis Investigative Site - Aurora
Maryland
- Novartis Investigative Site - Baltimore
New Jersey
- Novartis Investigative Site - Livingston
Ohio
- Novartis Investigative Site - Cincinnati
São Paulo
- Novartis Investigative Site - São Paulo
The Netherlands
- Novartis Investigative Site - Utrecht
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2015-02-05 |
| Est. Completion | 2017-11-29 |
| Phase | Phase 1 |
What the finished NCT02217410 record still lists
NCT02217410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 266-participant average among 33 other Kidney Transplantation trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Kidney Transplantation appearing as the primary indexed condition, and to 5 interventions - of which Tacrolimus (Tac) is the first listed.
NCT02217410 lists 14 locations in 8 states (Other, Michigan, Colorado).
Frequently Asked Questions
What is clinical trial NCT02217410 about?
NCT02217410 is a clinical study titled "CCFZ533X2201 - PoC Study in de Novo Renal Transplantation". The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allogr...
What is the current status of trial NCT02217410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2015-02-05. Estimated completion is 2017-11-29.
What conditions does trial NCT02217410 study?
This clinical trial studies the following conditions: Kidney Transplantation.
What interventions are being tested in trial NCT02217410?
The interventions under investigation include: Tacrolimus (Tac) (DRUG), Mycophenolate mofetil (MMF) (DRUG), CFZ533 (BIOLOGICAL), Corticosteroids (CS) (DRUG), anti-IL2 Induction (BIOLOGICAL).
Who is sponsoring clinical trial NCT02217410?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02217410 being conducted?
This trial has 14 study locations across Colorado, Maryland, Michigan, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02217410's enrollment target sits among peer trials
59 21st of 33 higher than 13 of 33 other Kidney Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplantation 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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Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
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Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
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