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NCT01064791 Clinical Trial

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

Renal Transplantation Clinical Trial

Official title:
A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01064791
Other study ID # CAEB071A2214
Secondary ID 2009-015456-14
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2009
Est. completion date August 2012

Study information
Verified date November 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 298
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor. - Recipients of a kidney with a cold ischemia time < 30 hours. - Recipients of a kidney from a donor 10 - 65 years old. Exclusion criteria: - Multi-organ transplant recipients. - Recipients of an organ from an non-heart beating donor. - Patients receiving a second kidney allograft if the first allograft was - Functional for less than three years - Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment. Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• sotrastaurin (Dose 1) + tacrolimus + standard of care medications
sotrastaurin (100mg bid) + tacrolimus + standard of care medications
• sotrastaurin (Dose 2) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
• sotrastaurin (Dose 3) + tacrolimus + standard of care medications
sotrastaurin (300mg bid) + tacrolimus + standard of care medications
• mycophenolic acid + tacrolimus + standard of care medications
mycophenolic acid (720mg bid) + tacrolimus + standard of care medications

Locations
Country Name City State
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Cordoba
Argentina Novartis Investigative Site Corrientes
Australia Novartis Investigative Site Adelaide South Australia
Australia Novartis Investigative Site Camperdown New South Wales
Australia Novartis Investigative Site Melbourne Victoria
Australia Novartis Investigative Site Woolloongabba Queensland
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Leuven
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site São Paulo SP
Canada Novartis Investigative Site Vancouver British Columbia
Colombia Novartis Investigative Site Cali
Denmark Novartis Investigative Site Aarhus
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Regensburg
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Szeged
Korea, Republic of Novartis Investigative Site Seoul Korea
Korea, Republic of Novartis Investigative Site Seoul Korea
Netherlands Novartis Investigative Site Rotterdam
Portugal Novartis Investigative Site Coimbra
Portugal Novartis Investigative Site Lisbon
Portugal Novartis Investigative Site Porto
Sweden Novartis Investigative Site Göteborg
Sweden Novartis Investigative Site Stockholm
Sweden Novartis Investigative Site Uppsala
United Kingdom Novartis Investigative Site Glasgow
United Kingdom Novartis Investigative Site Leicester
United Kingdom Novartis Investigative Site Manchester
United States Novartis Investigative Site Ann Arbor Michigan
United States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Birmingham Alabama
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Detroit Michigan
United States Novartis Investigative Site Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Colombia,  Denmark,  Germany,  Hungary,  Korea, Republic of,  Netherlands,  Portugal,  Sweden,  United Kingdom, 

References & Publications (1)

Russ GR, Tedesco-Silva H, Kuypers DR, Cohney S, Langer RM, Witzke O, Eris J, Sommerer C, von Zur-Mühlen B, Woodle ES, Gill J, Ng J, Klupp J, Chodoff L, Budde K. Efficacy of sotrastaurin plus tacrolimus after de novo kidney transplantation: randomized, pha — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination). Months 6, 12, 24, and 36
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