RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency

Phase 3

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: Calcineurin inhibitors (CNI); Drug: Everolimus; Drug: Mycophenolate acid (MPA)/ Azathioprine (AZA); Drug: Steroids

• Registration Number: NCT00267189
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-19
• Study First Posted: 2005-12-20
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2010-12-20
• Results First Submitted QC: 2011-03-08
• Status Verified: 2011-04
• Results First Posted: 2011-04-07
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduced CNI dose + everolimus ± steroids	Steroids	Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids
CNI continuation ± MPA/AZA ± Steroids	Mycophenolate acid (MPA)/ Azathioprine (AZA)	Standard CNI dose ± MPA/AZA ± steroids
CNI continuation ± MPA/AZA ± Steroids	Calcineurin inhibitors (CNI)	Standard CNI dose ± MPA/AZA ± steroids
Reduced CNI dose + everolimus ± steroids	Calcineurin inhibitors (CNI)	Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids
CNI continuation ± MPA/AZA ± Steroids	Steroids	Standard CNI dose ± MPA/AZA ± steroids
Reduced CNI dose + everolimus ± steroids	Everolimus	Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)	From baseline to 6 months	The primary variable was renal function assessed by calculated creatinine clearance using the Cockcroft-Gault formula, and was assessed at all visits.; CrCl\[mL/min\] = (140 - A) \* W / (72 \* C) \* R. Where A is age at sample date \[years\], W is body weight at specific visit \[kg\], C is the serum concentration of creatinine \[mg/dL\], R = 1 if the patient is male and = 0.85 if female.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Discontinuation of Study Medication	6 months
Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)	6 months	The composite efficacy failure endpoint encompasses at least one of: biopsy proven acute rejection, graft loss, or death for the patient. BPAR was defined as a clinically suspected acute rejection confirmed by biopsy. Acute rejection episodes were recorded as Liver Allograft Rejection. The allograft was presumed to be lost if a patient had a liver retransplant or died.

Trial Locations

Locations (2)

Novartis Investigative Site; 🇨🇭 Basel, Switzerland

Novartis Investigational Site; 🇩🇪 Germany, Germany