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

Novartis

Status and phase: Withdrawn; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01269684

CRAD001ACH04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Primary or secondary renal transplantation in the past 12-36 months.
• Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
• Moderately impaired renal function

Exclusion criteria

• Multi-organ recipients or previous transplantation with an organ other than a kidney.
• Acute rejection episodes in the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

1

Experimental group

Description:

Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml

Treatment:

Drug: Everolimus