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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
Country [2] 0 0
Argentina
State/province [2] 0 0
Chaco
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Santa Fe
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Estonia
State/province [8] 0 0
Tartu
Country [9] 0 0
France
State/province [9] 0 0
Brest
Country [10] 0 0
France
State/province [10] 0 0
Nice Cedex 1
Country [11] 0 0
France
State/province [11] 0 0
Toulouse Cedex 4
Country [12] 0 0
France
State/province [12] 0 0
Tours Cedex
Country [13] 0 0
France
State/province [13] 0 0
Vandoeuvre Les Nancy
Country [14] 0 0
Germany
State/province [14] 0 0
Aachen
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
Frankfurt am Main
Country [18] 0 0
Germany
State/province [18] 0 0
Hamburg
Country [19] 0 0
Germany
State/province [19] 0 0
Hannover Muenden
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Germany
State/province [21] 0 0
Muenster
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Patras
Country [24] 0 0
India
State/province [24] 0 0
Andhra Pradesh
Country [25] 0 0
India
State/province [25] 0 0
Delhi
Country [26] 0 0
India
State/province [26] 0 0
Karnataka
Country [27] 0 0
India
State/province [27] 0 0
Uttar Pradesh
Country [28] 0 0
India
State/province [28] 0 0
New Delhi
Country [29] 0 0
Italy
State/province [29] 0 0
BO
Country [30] 0 0
Italy
State/province [30] 0 0
PD
Country [31] 0 0
Italy
State/province [31] 0 0
RM
Country [32] 0 0
Italy
State/province [32] 0 0
SI
Country [33] 0 0
Italy
State/province [33] 0 0
TO
Country [34] 0 0
Latvia
State/province [34] 0 0
Riga
Country [35] 0 0
Lithuania
State/province [35] 0 0
Vilnius
Country [36] 0 0
Mexico
State/province [36] 0 0
Coahuila
Country [37] 0 0
Mexico
State/province [37] 0 0
Distrito Federal
Country [38] 0 0
Mexico
State/province [38] 0 0
Aguascalientes
Country [39] 0 0
Mexico
State/province [39] 0 0
Veracruz
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Groningen
Country [42] 0 0
Netherlands
State/province [42] 0 0
Leiden
Country [43] 0 0
Norway
State/province [43] 0 0
Oslo
Country [44] 0 0
Portugal
State/province [44] 0 0
Lisboa
Country [45] 0 0
Portugal
State/province [45] 0 0
Lisbon
Country [46] 0 0
Portugal
State/province [46] 0 0
Porto
Country [47] 0 0
Romania
State/province [47] 0 0
Jud Cluj
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Krasnodar
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Nizhnii Novgorod
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Novosibirsk
Country [52] 0 0
Russian Federation
State/province [52] 0 0
S.-Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Samara
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Volzhskiy
Country [55] 0 0
Spain
State/province [55] 0 0
Andalucia
Country [56] 0 0
Spain
State/province [56] 0 0
Cantabria
Country [57] 0 0
Spain
State/province [57] 0 0
Catalunya
Country [58] 0 0
Spain
State/province [58] 0 0
Cataluña
Country [59] 0 0
Spain
State/province [59] 0 0
Galicia
Country [60] 0 0
Spain
State/province [60] 0 0
Zaragoza
Country [61] 0 0
Thailand
State/province [61] 0 0
THA
Country [62] 0 0
Thailand
State/province [62] 0 0
Bangkok
Country [63] 0 0
Turkey
State/province [63] 0 0
Antalya
Country [64] 0 0
Turkey
State/province [64] 0 0
Büyükçekmece / Ýstanbul
Country [65] 0 0
Turkey
State/province [65] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01114529