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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01064791




Registration number
NCT01064791
Ethics application status
Date submitted
2/02/2010
Date registered
8/02/2010
Date last updated
22/12/2020

Titles & IDs
Public title
Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
Scientific 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
Secondary ID [1] 0 0
2009-015456-14
Secondary ID [2] 0 0
CAEB071A2214
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sotrastaurin (Dose 1) + tacrolimus + standard of care medications
Treatment: Drugs - sotrastaurin (Dose 2) + tacrolimus + standard of care medications
Treatment: Drugs - sotrastaurin (Dose 3) + tacrolimus + standard of care medications
Treatment: Drugs - mycophenolic acid + tacrolimus + standard of care medications

Experimental: Arm 1 - sotrastaurin (100mg bid) + tacrolimus + standard of care medications

Experimental: Arm 2 - sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Experimental: Arm 3 - sotrastaurin (300mg bid) + tacrolimus + standard of care medications

Active Comparator: Arm 4 - mycophenolic acid (720mg bid) + tacrolimus + standard of care medications


Treatment: Drugs: sotrastaurin (Dose 1) + tacrolimus + standard of care medications
sotrastaurin (100mg bid) + tacrolimus + standard of care medications

Treatment: Drugs: sotrastaurin (Dose 2) + tacrolimus + standard of care medications
sotrastaurin (200mg bid) + tacrolimus + standard of care medications

Treatment: Drugs: sotrastaurin (Dose 3) + tacrolimus + standard of care medications
sotrastaurin (300mg bid) + tacrolimus + standard of care medications

Treatment: Drugs: mycophenolic acid + tacrolimus + standard of care medications
mycophenolic acid (720mg bid) + tacrolimus + standard of care medications
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Month 6
Secondary outcome [1] 0 0
Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)
Timepoint [1] 0 0
Months 6, 12, 24, and 36
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
Months 12, 24, and 36
Secondary outcome [3] 0 0
Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).
Timepoint [3] 0 0
Months 6, 12, 24, and 36
Secondary outcome [4] 0 0
Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).
Timepoint [4] 0 0
Months 6, 12, 24, and 36

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
298
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Argentina
State/province [6] 0 0
Cordoba
Country [7] 0 0
Argentina
State/province [7] 0 0
Corrientes
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Leuven
Country [10] 0 0
Brazil
State/province [10] 0 0
RS
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Colombia
State/province [13] 0 0
Cali
Country [14] 0 0
Denmark
State/province [14] 0 0
Aarhus
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Essen
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Hannover
Country [19] 0 0
Germany
State/province [19] 0 0
Heidelberg
Country [20] 0 0
Germany
State/province [20] 0 0
Koeln
Country [21] 0 0
Germany
State/province [21] 0 0
Regensburg
Country [22] 0 0
Hungary
State/province [22] 0 0
Budapest
Country [23] 0 0
Hungary
State/province [23] 0 0
Szeged
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Korea
Country [25] 0 0
Netherlands
State/province [25] 0 0
Rotterdam
Country [26] 0 0
Portugal
State/province [26] 0 0
Coimbra
Country [27] 0 0
Portugal
State/province [27] 0 0
Lisbon
Country [28] 0 0
Portugal
State/province [28] 0 0
Porto
Country [29] 0 0
Sweden
State/province [29] 0 0
Göteborg
Country [30] 0 0
Sweden
State/province [30] 0 0
Stockholm
Country [31] 0 0
Sweden
State/province [31] 0 0
Uppsala
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Glasgow
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Leicester
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01064791
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01064791