Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

Phase 2

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications; Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications; Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications; Drug: mycophenolic acid + tacrolimus + standard of care medications

• Registration Number: NCT01064791
• 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 renal transplantation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• 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: 298

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	sotrastaurin (Dose 1) + tacrolimus + standard of care medications	sotrastaurin (100mg bid) + tacrolimus + standard of care medications
Arm 2	sotrastaurin (Dose 2) + tacrolimus + standard of care medications	sotrastaurin (200mg bid) + tacrolimus + standard of care medications
Arm 3	sotrastaurin (Dose 3) + tacrolimus + standard of care medications	sotrastaurin (300mg bid) + tacrolimus + standard of care medications
Arm 4	mycophenolic acid + tacrolimus + standard of care medications	mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Primary Outcome Measures

Name	Time	Method
Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).	Month 6

Secondary Outcome Measures

Name	Time	Method
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)	Months 6, 12, 24, and 36
Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).	Months 12, 24, and 36
Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).	Months 6, 12, 24, and 36
Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).	Months 6, 12, 24, and 36

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Manchester, United Kingdom