Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Phase 4

Withdrawn

• Conditions: Kidney Transplantation
• Interventions: Drug: Everolimus

• Registration Number: NCT01269684
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.

Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Everolimus	Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Primary Outcome Measures

Name	Time	Method
Routine safety laboratory	Month 6

Secondary Outcome Measures

Name	Time	Method
renal function	Months 1, 2, 4 and 6

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zurich, Switzerland