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Kidney TransplantationPhase 3ELEVATENCT01114529

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

A Phase 3 study testing Everolimus and Prograf or Neoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 77 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Kidney Transplantation
What is being tested?
Everolimus and Prograf or Neoral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
828 participants
Where
77 sitesin 21 countries
Study dates
9 Aug 2010to 30 Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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).

Who cannot join

  • 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.
Show all 31Show fewer
  • 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
  • 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.

Trial locations and contacts

77 sites in 21 countries.

77 sites in 21 countries

Germany8 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt am Main, 60596

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hannover Muenden, 34346

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Münster, 48149

Other trials in Germany

Russia8 sites

  • Novartis Investigative Site

    Krasnodar, 350086

  • Novartis Investigative Site

    Moscow, 115446

  • Novartis Investigative Site

    Moscow, 123182

  • Novartis Investigative Site

    Nizhny Novgorod, 603000

  • Novartis Investigative Site

    Novosibirsk, 630087

  • Novartis Investigative Site

    S.-Petersburg, 192242

  • Novartis Investigative Site

    Samara, 443079

  • Novartis Investigative Site

    Volzhskiy, 404120

Other trials in Russia

Argentina7 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1118AAT

  • Novartis Investigative Site

    Córdoba, X5016JDA

  • Novartis Investigative Site

    Córdoba, X5016KEH

  • Novartis Investigative Site

    Córdoba, X5022CPU

  • Novartis Investigative Site

    Resistencia, Chaco Province, H3508AZP

  • Novartis Investigative Site

    San Martín, Buenos Aires, C1107BEA

  • Novartis Investigative Site

    Santa Fe, S3000EPV

Other trials in Argentina

Spain7 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

France5 sites

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Nice, 06602

  • Novartis Investigative Site

    Toulouse, 31054

  • Novartis Investigative Site

    Tours, 37044

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

India5 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 055

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017

  • Novartis Investigative Site

    New Delhi, 110044

  • Novartis Investigative Site

    Visakhapatnam, Andhra Pradesh

Other trials in India

Italy5 sites

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Roma, RM, 00144

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Torino, TO, 10126

Other trials in Italy

Australia4 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Clayton, Victoria, 3168

  • Novartis Investigative Site

    Melbourne, Victoria, 3050

Other trials in Australia

Mexico4 sites

  • Novartis Investigative Site

    Aguascalientes, 20230

  • Novartis Investigative Site

    Mexico City, Mexico City, 14080

  • Novartis Investigative Site

    Torreón, Coahuila, 27250

  • Novartis Investigative Site

    Veracruz, 91700

Other trials in Mexico

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Antalya, 07000

  • Novartis Investigative Site

    Büyükçekmece / Ýstanbul, 34520

  • Novartis Investigative Site

    Fatih / Istanbul, 34098

  • Novartis Investigative Site

    Istanbul, 34093

Other trials in Turkey (Türkiye)

Austria3 sites

  • Novartis Investigative Site

    Linz, A-4010

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Greece3 sites

  • Novartis Investigative Site

    Athens, GR 11527

  • Novartis Investigative Site

    Athens, GR-106 76

  • Novartis Investigative Site

    Pátrai, Greece, 265 00

Other trials in Greece

Netherlands3 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Leiden, 2300 RC

Other trials in Netherlands

Portugal3 sites

  • Novartis Investigative Site

    Carnaxide - Linda-A-Velha, Lisbon District, 2790-134

  • Novartis Investigative Site

    Lisbon, 1069-166

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

Belgium1 site

  • Novartis Investigative Site

    Leuven, 3000

Other trials in Belgium

Estonia1 site

  • Novartis Investigative Site

    Tartu, 51014

Other trials in Estonia

Latvia1 site

  • Novartis Investigative Site

    Riga, 1002

Other trials in Latvia

Lithuania1 site

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Norway1 site

  • Novartis Investigative Site

    Oslo, 0424

Other trials in Norway

Romania1 site

  • Novartis Investigative Site

    Cluj-Napoca, Jud Cluj, 400006

Other trials in Romania

About this study

Official 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

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

Read the detailed description

This was a 24-month, multi-center, randomized, open-label trial with two parallel arms in adult de novo renal allograft recipients. The study consisted of a run-in period from transplantation to Randomization and a treatment period from Randomization until Month 24. At baseline visit, patients were transplanted and entered the run-in period from transplantation (Baseline) to Randomization (week 10-14 post-transplantation). At Week 10-14, eligible patients were randomized into one of the 2 treatment arms: standard CNIs and Myfortic versus everolimus and Myfortic and entered the treatment period of the study from Randomization to Month 24. Patients in both arms received steroids as per center practice and in any caseat least 5 mg/Day. At Randomization, patients were stratified according to their renal allograft function and previous cardiovascular events. The main analysis was performed at Month 12 and the follow-up analysis was performed at Month 24.

Being tested
Everolimus, Prograf or Neoral
Keywords
de novo renal allograft recipients, renal allograft function, CNI-free regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Certican, Zortress, RAD001

    Early CNI to everolimus conversion

  • Prograf or NeoralDrug

    Also called Tacrolimus or Cyclosporine

    Active CNI-based control (Prograf or Neoral)

Study groups in NCT01114529
Study groupRoleWhat they receive
EverolimusExperimentalConversion from CNI to everolimus in combination with Myfortic and steroids
Receives: Drug: Everolimus
Calcineurin inhibitor, Prograf or NeoralActive comparatorControl arm: CNI continuation, either Prograf or Neoral in combination with Myfortic and steroids
Receives: Drug: Prograf or Neoral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated Glomerular Filtration Rate (eGFR)

    Assessment of renal function by comparing change from randomization to Month 12 in eGFR (MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = serum concentration of creatinine [mg/dL]; A = age [years]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1

    Measured: Month 12

Secondary outcomes (3)

  1. Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24

    Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss, or (3) death . *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted.

    Measured: at 12 months and month 24 post-transplantation

  2. Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24

    Evolution of left ventricular mass and hypertrophy were evaluated by left ventricular mass index (LVMi) assessed by echocardiography. LVMi is derived using a standard formula from dimensional measurements on the echocardiogram. Analysis of covariance was applied with treatment, center (as a random effect), and donor type as factors and LVMi at Randomization as covariate.

    Measured: Randomization, Month 12 and Month 24

  3. Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis)

    (treated BPAR ≥ IB, graft loss or death)A comparison of the incidence rates for the individual components of the composite efficacy endpoint between treatment arms

    Measured: at 24 months post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2010 (estimated)
  2. Study start9 Aug 2010
  3. Primary completion30 Oct 2014
  4. Study completion30 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
828 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01114529
Sponsor's protocol ID
CRAD001A2429
Other IDs
2009-015918-22, 2009
Acronym
ELEVATE
Status last verified
Apr 2017
First submitted
27 Apr 2010
Last updated
30 May 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus and Prograf or Neoral in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 77 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Germany, Russia, Argentina, Spain, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated Glomerular Filtration Rate (eGFR) (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01114529.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

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