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Multicenter, randomized, open-label trial to evaluate the safety, tolerability and efficacy of two regimens of Everolimus plus Neoral, given according different blood target levels, in de novo renal transplant recipients Everest the upper target EVErolimus RandomizEd STudy

Multicenter, randomized, open-label trial to evaluate the safety, tolerability and efficacy of two regimens of Everolimus plus Neoral, given according different blood target levels, in de novo renal transplant recipients Everest the upper target EVErolimus RandomizEd STudy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000864-16-IT
Enrollment
200
Registered
2005-12-15
Start date
2005-04-12
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Prevention of rejection in adult renal transplant patients in combination with Neoral and corticosteroids MedDRA version: 6.1 Level: PT Classification code 10023439

Interventions

Product Name: everolimus Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .25- Prod

Sponsors

NOVARTIS FARMA
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 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):—

Countries

Italy

Outcome results

None listed

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