Clinical trial
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and…
NCT03663335 · Novartis Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT03663335 |
|---|---|
| Title | Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients |
| 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) |
| Acronym | CIRRUS I |
| Lead sponsor | Novartis Pharmaceuticals, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Kidney Transplant Rejection |
| Intervention type | Biological, Drug |
| Interventions | CFZ533 - MMF - CS, Tacrolimus - MMF - +/- corticosteroids |
| Enrollment | 418 |
| Start date | Nov 28, 2018 |
| Primary completion | Oct 29, 2021 |
| Completion | Oct 29, 2021 |
| First posted | Sep 10, 2018 |
| Last update posted | Jun 13, 2022 |
| Countries | Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Japan, Latvia and 8 more |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: