WHO ICTRP trial
A partially-blinded, active-controlled, multicenter, randomized study evaluating…
NL-OMON55663 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON55663 |
|---|---|
| Public 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, CCFZ553A2201) |
| Scientific 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, CCFZ553A2201) - CIRRUS I |
| Primary sponsor | Novartis |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 2 |
| Countries | Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea (the Republic of);Latvia;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom;United States of America |
| Conditions | niertransplantatie kidney transplantation;10038430;kidney transplantation |
| Interventions | Cohort 1 * de novo patients: Arm 1: CFZ533 30 mg/kg IV (Day 1), CFZ533 15 mg/kg IV (Day 5), then CFZ533 600 mg SC Q2W (from Day 15) + MMF + corticosteroids (n=75) Arm 2: CFZ533 30 mg/kg IV (Day 1), CFZ533 15 mg/kg IV (Day 5), then CFZ533… |
| Registration date | May 12, 2021 |
| Target size | 35 |
| Secondary IDs | 2017-003607-22;NCT03663335;NL66119.078.18 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: