Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
Public ClinicalTrials.gov record NCT03663335. 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 Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Study identification
- NCT ID
- NCT03663335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 418 participants
Conditions and interventions
Conditions
Interventions
- CFZ533 - Cohort 1/Cohort 2 Biological
- Mycophenolate Mofetil (MMF) Drug
- Corticosteroids (CS) Drug
- Tacrolimus Drug
- Induction therapy: basiliximab Drug
- Induction therapy: rabbit anti-thymocyte globulin (rATG) Drug
- Maintenance population: EC-MPS Drug
- Maintenance population: MMF Drug
- Placebo 1 mL Drug
Biological · 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
- Nov 28, 2018 (Actual)
- Primary completion
- Oct 29, 2021 (Actual)
- Completion
- Oct 29, 2021 (Actual)
- Last update posted
- Mar 23, 2026
2018 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90033 | — |
| Novartis Investigative Site | San Francisco | California | 94143 0116 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Chicago | Illinois | 60611 | — |
| Novartis Investigative Site | Chicago | Illinois | 60612 | — |
| Novartis Investigative Site | Kansas City | Kansas | 66103 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202 2689 | — |
| Novartis Investigative Site | St Louis | Missouri | 63110 | — |
| Novartis Investigative Site | Durham | North Carolina | 27710 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45267-0585 | — |
| Novartis Investigative Site | Dallas | Texas | 75390 | — |
| Novartis Investigative Site | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03663335, 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 Mar 23, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03663335 live on ClinicalTrials.gov.