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

Kidney Transplantation Clinical Trial

— HERMES  

Official title:

A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01269684
• Other study ID #: CRAD001ACH04
• Status: Withdrawn
• Phase: Phase 4
• First received: October 5, 2010
• Last updated: February 23, 2017
• Start date: August 2008
• Est. completion date: August 2008

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Novartis Investigative Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine safety laboratory		At baseline
Primary	Routine safety laboratory		Week 1
Primary	Routine safety laboratory		Month 1
Primary	Routine safety laboratory		Week 2
Primary	Routine safety laboratory		Week 3
Primary	Routine safety laboratory		Month 2
Primary	Routine safety laboratory		Month 4
Primary	Routine safety laboratory		Month 6
Secondary	renal function		At baseline
Secondary	renal function		Weeks 1, 2 and 3
Secondary	renal function		Months 1, 2, 4 and 6