Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.

PHASE4TerminatedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Renal Transplantation
Interventions
DRUG

Everolimus

Participants, switching from the CsA based treatment, initially received everolimus 1.5 mg/day and then from day 7, 3 mg/day, and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml). Participants, switching from the tacrolimus based treatment, initially received 3 mg/day and then from day 14, the dose was based on the participants' blood level (6-10 ng/ml).

DRUG

Cyclosporin A (CsA)

The dose was based on the participants' blood level of C0h (80-150 ng/ml).

DRUG

Tacrolimus

The dose was based on the participants' blood level of C0h (5-10 ng/ml).

DRUG

Enteric Coated - Mycophenolate Sodium (EC-MPS)

The dose was ≥ 720 mg/day.

DRUG

Corticosteroids

Corticosteroids were given according to local standard and/or the Investigators' discretion.

Trial Locations (11)

10098

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

24105

Novartis Investigative Site, Kiel

30625

Novartis Investigative Site, Hanover

45122

Novartis Investigative Site, Essen

48149

Novartis Investigative Site, Münster

51109

Novartis Investigative Site, Cologne

67655

Novartis Investigative Site, Kaiserslautern

69115

Novartis Investigative Site, Heidelberg

74076

Novartis Investigative Site, Heilbronn

91054

Novartis Investigative Site, Erlangen

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY