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Evaluation de la pharmacodynamie, de l’efficacité et de la tolérance de 2 doses de Simulect® (40 ou 80 mg) en association ou non à un inhibiteur de la calcineurine.

- IDEALE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024231-16-FR
Enrollment
50
Registered
2011-04-08
Start date
2011-06-21
Completion date
Unknown
Last updated
2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal transplantation

Interventions

Trade Name: Simulect Product Name: Simulect Product Code: CHI621 Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: basiliximab Current Sponsor code: CHI6

Sponsors

Novartis Pharma S.A.S
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):

Secondary

MeasureTime frame
Secondary end point(s): ­

Countries

France

Contacts

Public ContactInformation&Communication Médicales

Novartis Pharma S.A.S

icm.phfr@novartis.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026