Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

Phase 2

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: MMF(1000mg bid) + tacrolimus + standard of care medications; Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications; Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

• Registration Number: NCT01128335
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2016-11
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	MMF(1000mg bid) + tacrolimus + standard of care medications	MMF(1000mg bid) + tacrolimus + standard of care medications
Arm 2	sotrastaurin (200mg bid) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 3	sotrastaurin (200mg bid) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 4	sotrastaurin (300 mg bid) + tacrolimus + standard of care medications	sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Primary Outcome Measures

Name	Time	Method
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.	Month 6

Secondary Outcome Measures

Name	Time	Method
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).	Months 3, 6, 12, and 24
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.	Months 12, 24
Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant	Months 6, 12, 24
Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).	Months 3, 6, 12, 24

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zurich, Switzerland