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a randomized, open-label study to evaluate the safety and efficacy of delayed introduction of sirolimus and concomitant tacrolimus elimination in de novo renal allograft recipients - early transition from tacrolimus to sirolimus

a randomized, open-label study to evaluate the safety and efficacy of delayed introduction of sirolimus and concomitant tacrolimus elimination in de novo renal allograft recipients - early transition from tacrolimus to sirolimus

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-016762-87-IT
Enrollment
Unknown
Registered
2009-11-04
Start date
2006-03-24
Completion date
Unknown
Last updated
2012-10-02

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

Conditions

no MedDRA version: 9.1 Level: SOC Classification code 10038359

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: syrolinus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1-

Sponsors

OSPEDALE MAGGIORE DI MILANO (IRCCS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: low immunological risk recipients of a de novo renal transplant 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregancy status, early acute rejection, infections, neoplasia,

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the equivalent efficacy of the experimental protocol as compared to the traditional immunesuppressive regimen on graft survival at the 1st year;Secondary Objective: to evaluate the difference in safety profile;Primary end point(s): graft survival—

Countries

Italy

Outcome results

None listed

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