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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01114529




Registration number
NCT01114529
Ethics application status
Date submitted
27/04/2010
Date registered
3/05/2010
Date last updated
30/05/2017

Titles & IDs
Public title
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
Scientific title
A 24-month, Multi-center, Open-label, Randomized, Controlled Trial to Investigate Efficacy, Safety and Evolution of Cardiovascular Parameters in de Novo Renal Transplant Recipients After Early Calcineurin Inhibitor to Everolimus Conversion
Secondary ID [1] 0 0
2009-015918-22
Secondary ID [2] 0 0
CRAD001A2429
Universal Trial Number (UTN)
Trial acronym
ELEVATE
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Everolimus
Treatment: Drugs - Prograf or Neoral

Experimental: Everolimus - Conversion from CNI to everolimus in combination with Myfortic and steroids

Active comparator: Calcineurin inhibitor, Prograf or Neoral - Control arm: CNI continuation, either Prograf or Neoral in combination with Myfortic and steroids


Treatment: Drugs: Everolimus
Early CNI to everolimus conversion

Treatment: Drugs: Prograf or Neoral
Active CNI-based control (Prograf or Neoral)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated Glomerular Filtration Rate (eGFR)
Timepoint [1] 0 0
Month 12
Secondary outcome [1] 0 0
Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24
Timepoint [1] 0 0
at 12 months and month 24 post-transplantation
Secondary outcome [2] 0 0
Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24
Timepoint [2] 0 0
Randomization, Month 12 and Month 24
Secondary outcome [3] 0 0
Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis)
Timepoint [3] 0 0
at 24 months post-transplantation

Eligibility
Key inclusion criteria
Inclusion Criteria at Baseline:

* Male or female renal allograft recipients at least 18 years old.
* Written informed consent.
* Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor.
* Cold ischemia time (CIT) < 24 hours.
* Negative pregnancy test for female patients.

Inclusion Criteria at Randomization:

* Patients on CNI (TAC or CsA) + Myfortic + steroids.
* Serum creatinine < 2.8 mg/dL (250 µmol/L) and an actual eGFR (MDRD4) = 25 mL/min/1.73m exp2 (without renal replacement therapy).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria at Baseline:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

* Recipient of multiple organ transplants.
* Recipient of ABO incompatible allograft or a positive cross-match.
* Panel Reactive Antibodies (PRA) level = 30 %.
* Positive test for human immunodeficiency virus (HIV).
* Patient receiving an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor.
* HBsAg and/or a HCV positive patient with evidence of elevated LFTs (ALT/AST levels = 2.5 times ULN).
* Severe restrictive or obstructive pulmonary disorders.
* Patient with severe allergy requiring acute or chronic treatment or hypersensitivity to any of the study drugs or similar drugs.
* Severe hypercholesterolemia or hypertriglyceridemia.
* Low platelet count.
* Low white blood cell count.
* History of malignancy of any organ system

Exclusion Criteria at Randomization:

* Graft loss.
* Patient on renal replacement therapy.
* Patient who experienced severe humoral and/or cellular rejection (BANFF = IIb).
* Patient with = 2 episodes of AR or an AR episode that needed antibody treatment.
* Patient with ongoing or currently treated AR (2 weeks prior to randomization).
* Proteinuria > 1 g/day.
* Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS).
* Low platelet count; Low white blood cell count; Low absolute neutrophil count; Low hemoglobin.
* Severe liver disease.
* Systemic infection requiring continued therapy that would interfere with the objectives of the study.
* Severe hypercholesterolemia or hypertriglyceridemia.
* Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy.
* Presence of intractable immunosuppressant complications or side effects.
* Patients on anticoagulants that prevents renal allograft biopsy.
* Use of prohibited medication.
* Use of immunosuppressive agents not utilized in the protocol.
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential not using a highly effective method of birth control.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
9/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2014
Sample size
Target
Accrual to date
Final
828
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [4] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
State/province [2] 0 0
Chaco
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Austria
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Linz
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Austria
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Wien
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Belgium
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Leuven
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Estonia
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Tartu
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France
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Brest
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France
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Nice Cedex 1
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France
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Toulouse Cedex 4
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France
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Tours Cedex
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France
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Vandoeuvre Les Nancy
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Essen
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Hannover Muenden
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Germany
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Heidelberg
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Germany
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Muenster
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Greece
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Athens
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Greece
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Patras
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India
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Andhra Pradesh
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India
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Delhi
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India
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Karnataka
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India
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Uttar Pradesh
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India
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New Delhi
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Italy
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BO
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Italy
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PD
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Italy
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RM
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Italy
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SI
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Italy
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TO
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Latvia
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Riga
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Lithuania
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Vilnius
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Mexico
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Coahuila
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Mexico
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Distrito Federal
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Mexico
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Aguascalientes
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Mexico
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Veracruz
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leiden
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Norway
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Oslo
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Romania
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Jud Cluj
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Nizhnii Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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S.-Petersburg
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Russian Federation
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Samara
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Russian Federation
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Volzhskiy
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Spain
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Andalucia
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Spain
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Cantabria
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Spain
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Catalunya
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Spain
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Cataluña
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Spain
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Galicia
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Spain
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Zaragoza
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Thailand
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THA
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Thailand
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Bangkok
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Turkey
State/province [63] 0 0
Antalya
Country [64] 0 0
Turkey
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Büyükçekmece / Ýstanbul
Country [65] 0 0
Turkey
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Fatih / Istanbul
Country [66] 0 0
Turkey
State/province [66] 0 0
Istanbul

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients
Trial website
https://clinicaltrials.gov/study/NCT01114529
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/study/NCT01114529