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A 12-month, multicenter, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican (1.5 mg/day starting dose) with reduced Neoral dose versus MMF with standard Neoral dose in de novo heart transplant recipients

A 12-month, multicenter, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican (1.5 mg/day starting dose) with reduced Neoral dose versus MMF with standard Neoral dose in de novo heart transplant recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001052-36-IT
Enrollment
Unknown
Registered
2005-04-07
Start date
2004-11-24
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

Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic cardiac transplant. The drug should be used in combination with ciclosporin for microemulsion and corticosteroids. MedDRA version: 6.1 Level: PT Classification code 10019315

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: .75- Trad

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

Germany, Italy, Spain

Outcome results

None listed

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