CIRRUS I: Studie zur Beurteilung der Wirksamkeit und Sicherheit von Iscalimab (CFZ533) bei nierentransplantierten Patienten

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

In dieser klinischen Studie wird die Wirksamkeit und Sicherheit von Iscalimab untersucht, die Abstossung der transplantierten Niere zu verhindern. Darüber hinaus möchten wir herausfinden, ob Iscalimab im Vergleich zu einer Standardtherapie mit Tacrolimus gleich gut oder besser ist. Iscalimab ist ein Medikament, das weder von Swissmedic noch irgendeiner anderen Gesundheitsbehörde in einem anderen Land zugelassen wurde. Patienten werden per Zufallsverfahren entweder Iscalimab- oder Tacrolimus Behandlungsschema zugewiesen. Es gibt zwei Patientengruppen in dieser Studie: Gruppe 1 – Patienten, die gerade eine neue Niere erhalten haben. Gruppe 2 – Patienten, die zwischen 6 und 24 Monaten vor Aufnahme in die Studie eine neue Niere erhalten haben. In der Gruppe 1 liegt die Wahrscheinlichkeit, eine Behandlung mit Iscalimab zu erhalten bei 75 % und die Tacrolimus zu erhalten bei 25 %. In der Gruppe 2 liegt die Wahrscheinlichkeit, eine Iscalimab-Behandlung zu erhalten bei 60 % und die einer Tacrolimus-Behandlung bei 40 %. Es werden ungefähr 681 Patienten weltweit an dieser Studie teilnehmen; etwa 6 von ihnen in der Schweiz.

Malattie studiate(Fonte di dati: BASEC)

Nierentransplantation

Health conditions (Fonte di dati: WHO)

Renal transplantation
MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Malattia rara (Fonte di dati: BASEC)

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Die Studienteilnehmer erhalten alle zwei Wochen Iscalimab Injektionen unter die Haut oder werden täglich Tacrolimus Kapseln nehmen. Die Behandlung dauert fünf Jahre. Während dieser Zeit werden zu verschiedenen Zeitpunkten Blutproben entnommen um zu beurteilen, ob die Studienbehandlung eine Wirkung zeigt.

Interventions (Fonte di dati: WHO)

Product Name: Not established
Product Code: CFZ533
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not established
Current Sponsor code: CFZ533
Other descriptive name: CFZ533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

- Männliche oder weibliche Patienten ab 18 Jahre
- Patienten, bei denen eine Nierentransplantation geplant ist oder bei denen eine solche in den letzten zwei Jahren durchgeführt wurde

Criteri di esclusione (Fonte di dati: BASEC)

- Patienten, denen mehrere Organe oder beide Nieren transplantiert wurden

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Inclusion criteria:
1.Male or female patient = 18 years old.
2. Up to date vaccination
3.Recipients of a primary kidney transplant from a brain-dead donor (DBD), living unrelated or non-HLA identical living related donor (cohort1).
4.Recipients of a kidney with a cold ischemia time (CIT) < 24 hours (cohort 1)
5. Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen
containing Tac+MMF±CS (Cohort 2)
6.Patients with an actual eGFR = 45 mL/min/1.73m2 (Cohort 2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 621
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1.Multi-organ transplant recipients or prior kidney transplant (cohort 1 and 2)
2.Pregnant or nursing women (cohort 1 and 2)
3.Women of child bearing potential unless using highly effective methods of contraception during dosing and 12 weeks after study medication has been stopped (cohort 1 and 2)
4. Recipients of an organ from a donor after cardiac death (DCD) (cohort 1).
5. Recipient of an organ from an HLA identical living related donor (cohort 1).
6. Recipients of kidneys from donors who are older than 65 years (cohort 1).
7.Patients at high immunological risk for rejection (cohort 1)
8.DSA within 12 weeks prior enrollment (cohort 2)
9. Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment (cohort 2)
10. Severe humoral and/or cellular rejection (BANFF = IIb) before enrollment (cohort 2)

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003607-22

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2017-003607-22

Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

27 lug 2018

Inserimento del primo partecipante

12 ott 2018

Stato di reclutamento

Not Recruiting

Titolo scientifico (Fonte di dati: WHO)

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional clinical trial of medicinal product

Disegno della sperimentazione (Fonte di dati: WHO)

Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: partially- blinded If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 5

Fase (Fonte di dati: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Punti finali primari (Fonte di dati: WHO)

Main Objective: Cohort 1: to demonstrate that two CFZ533 dosing regimens are superior to a tacrolimus-based regimen with respect to the iBox risk prediction score at 12 months posttransplantation.
Cohort 2: To demonstrate that CFZ533 dosing regiment is superior to a tacrolimus-based regimen with respect to iBox risk prediction score at 12 months post conversion.;Secondary Objective: To demonstrate that two CFZ533 dosing regimens are superior to a tacrolimus based regimen with respect to the mean estimated glomerular filtration rate (eGFR) over 12 months post-transplantation in de novo patients
(cohort 1).
To demonstrate that two CFZ533 dosing regimens are non-inferior to the TAC based regimen with respect to the proportion of patients who experience the composite efficacy failure event (BPAR, Graft Loss or Death) over 12 months posttransplantation (cohort 1).

To demonstrate that CFZ533 is superior to a TAC-based regimen with respect to the mean change in eGFR from baseline to 12 months post conversion in maintenance patients (cohort2).
To demonstrate that CFZ533 dosing regimen is non-inferior to the TAC based regimen with respect to the proportion of patients who experience the composite efficacy failure event (BPAR, Graft Loss or Death) over 12
months post-conversion (cohort 2).;Primary end point(s): Cohort 1:
Mean iBox risk prediction score at 12 months post-transplantation
Cohort 2:
Mean iBox risk prediction score at month 12;Timepoint(s) of evaluation of this end point: -over 12 months from enrollment(cohort 1 and 2)

Punti finali secondari (Fonte di dati: WHO)

Secondary end point(s): -Mean eGFR at 12 months posttransplantation (Cohort 1)
- Proportion of patients with composite event (BPAR, Graft Loss or Death) over 12 months post-transplantation (Cohort 1)

-Mean change in eGFR from baseline to 12 months post conversion (Cohort 2).
-Proportion of patients with composite event (BPAR, Graft Loss or Death) over 12 months post conversion.
-Proportion of patients with AEs, SAEs, AEs of special interest (cohort 1 and 2)
-Free CFZ533 plasma concentrations over time (cohort 1 and 2);Timepoint(s) of evaluation of this end point: -at 12 months post-enrollment
-at 12 months post-enrollment
-at 12 months post-enrollment
-at 12 months post-enrollment
-continuously
-continuously

Contatto per informazioni (Fonte di dati: WHO)

Novartis Pharma AG

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

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)Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

Collegamento ai risultati nel registro primario

https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003607-22/results

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Berna, Zurigo

Paesi di esecuzione (Fonte di dati: WHO)

È possibile che la Svizzera non appaia ancora come paese di esecuzione perché non è ancora stata registrata nel registro primario dell’OMS.
Argentina, Australia, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Netherlands, Norway, Slovakia, Spain, Sweden, United Kingdom, United States

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

Kashan Ahmed
+41 79 586 83 15
kashan.ahmed@novartis.com

Contatto per informazioni generali (Fonte di dati: WHO)

Medical information
Box 1218
Novartis Sverige AB
+4687323200
medinfo.se@novartis.com

Contatto per informazioni scientifiche (Fonte di dati: WHO)