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)
Study identification
- NCT ID
- NCT03663335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 418 participants
Conditions and interventions
Conditions
Interventions
- CFZ533 - Cohort 1/Cohort 2 Biological
- Corticosteroids (CS) Drug
- Induction therapy: basiliximab Drug
- Induction therapy: rabbit anti-thymocyte globulin (rATG) Drug
- Maintenance population: EC-MPS Drug
- Maintenance population: MMF Drug
- Mycophenolate Mofetil (MMF) Drug
- Placebo 1 mL Drug
- Tacrolimus 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 27, 2018
- Primary completion
- Oct 28, 2021
- Completion
- Oct 28, 2021
- Last update posted
- Mar 22, 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 22, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03663335 live on ClinicalTrials.gov.