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Kidney TransplantationPhase 3ATHENANCT01843348

12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

A Phase 3 study testing Everolimus, Tacrolimus and Cyclosporin A in people with Kidney Transplantation and Renal Transplantation, run by Novartis Pharmaceuticals at 27 sites in 2 countries.

Completed

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

Official record
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Trial summary

This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation, Renal Transplantation
What is being tested?
Everolimus, Tacrolimus and Cyclosporin A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
612 participants
Where
27 sitesin 2 countries
Study dates
27 Dec 2012to 23 Mar 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient who had received a primary or secondary kidney transplant
  • Patients who were willing and from whom written informed consent was obtained
  • kidney allograft with a cold ischemia time (CIT) < 30 hours
  • negative pregnancy test prior to study enrollment

Who cannot join

  • --Multi-organ recipients
  • former Graft loss due to immunological reasons
  • Patients who received a kidney from a non-heart beating donor
  • A-B-0 incompatible transplants
  • a current Panel Reactive Antibody (PRA) level of > 20%
  • existing antibodies against the HLA-type of the receiving transplant
Show all 15Show fewer
  • a known hypersensitivity/contraindication to any of the immunosuppressants
  • Use of other investigational drugs
  • Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 8 g/dL
  • significant mental illness
  • history of malignancy during the last five years
  • HIV positive
  • uncontrolled hypercholesterolemia or hypertriglyceridemia
  • drug or alcohol abuse
  • pregnant or breast feeding women

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

Germany15 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bochum, 44892

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91052

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

France12 sites

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    Dijon, 21079

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Lyon, 69437

  • Novartis Investigative Site

    Nantes, 44035

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Poitiers, France, 86000

  • Novartis Investigative Site

    Saint-Priest-en-Jarez, 42277

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31054

Other trials in France

About this study

Official title: 12 Month, Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Certican® Based Regimen Either in Combination With Cyclosporin A or Tacrolimus

This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.

Being tested
Everolimus, Tacrolimus, Cyclosporin A, Enteric Coated Mycophenolate Sodium (EC-MPS), Mycophenolate mofetil (MMF)
Keywords
Transplant, Renal transplant, Rejection,allograf, Rejection, Xenograft rejection, Host vs graft disease, Kidney Transplant
Medical subject headings
Rejection, Psychology, Graft vs Host Disease

What participants receive

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

  • EverolimusDrug

    Also called Certican

  • TacrolimusDrug

    Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels

  • Cyclosporin ADrug

    Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml

  • Enteric Coated Mycophenolate Sodium (EC-MPS)Drug

    Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose

  • Mycophenolate mofetil (MMF)Drug

    Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose

  • CorticosteroidsDrug

    A minimum dose of 5 mg prednisolon or equivalent

  • SimulectDrug

    Also called Basiliximab

    Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.

Study groups in NCT01843348
Study groupRoleWhat they receive
TAC+MPAActive comparatorNot described
Receives: Drug: Tacrolimus; Drug: Enteric Coated Mycophenolate Sodium (EC-MPS); Drug: Mycophenolate mofetil (MMF); Drug: Corticosteroids; Drug: Simulect
TAC+CerticanExperimentalNot described
Receives: Drug: Everolimus; Drug: Tacrolimus; Drug: Corticosteroids; Drug: Simulect
CycA+CerticanExperimentalNot described
Receives: Drug: Everolimus; Drug: Cyclosporin A; Drug: Corticosteroids; Drug: Simulect

What is being measured

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

  1. Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens

    To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula:

    GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set

    Measured: One year post transplant

Secondary outcomes (10)

  1. Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12

    Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)

    Measured: Month 12 post transplant

  2. Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant

    Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

    Measured: Month 12 post transplant

  3. Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant

    Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

    Measured: Month 12 post transplant

  4. Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant

    Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

    Measured: Month 12 post transplant

  5. Percentage of Participants With Treatment Failure Endpoints at Month 12

    Treatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)

    Measured: Month 12 post transplant

  6. Percent of Participants With Delayed Graft Function and Slow Graft Function

    Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine >3.0 mg/dL at Day 5 post-transplantation. Full analysis set

    Measured: Post transplant to month 12

  7. Percent of Participants With Delayed Graft Function by Day

    Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.

    Measured: Post transplant up to day 7

  8. Percent of Participants With Viral Infections

    Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus

    Measured: Post transplant to month 12

  9. Percent of Participants With Wound Healing Complications During Study

    Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles

    Measured: Post transplant until individual reporting

  10. Duration of Wound Healing

    A wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).

    Measured: Post transplant until individual reporting

Timeline

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

  1. First posted30 Apr 2013 (estimated)
  2. Study start27 Dec 2012
  3. Primary completion23 Mar 2016
  4. Study completion23 Mar 2016

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
612 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843348
Sponsor's protocol ID
CRAD001ADE44
Other IDs
2011-005238-21
Acronym
ATHENA
Status last verified
Mar 2017
First submitted
18 Apr 2013
Last updated
1 May 2017
Data monitoring committee
Yes

Publications

  • Philippe A, Arns W, Ditt V, Hauser IA, Thaiss F, Sommerer C, Suwelack B, Dragun D, Hillen J, Schiedel C, Elsasser A, Nashan B. Impact of everolimus plus calcineurin inhibitor on formation of non-HLA antibodies and graft outcomes in kidney transplant recipients: 12-month results from the ATHENA substudy. Front Transplant. 2023 Nov 21;2:1273890. doi: 10.3389/frtra.2023.1273890. eCollection 2023.

    PubMed 38993854

  • Sommerer C, Suwelack B, Dragun D, Schenker P, Hauser IA, Nashan B, Thaiss F. Design and rationale of the ATHENA study--A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial. Trials. 2016 Feb 17;17:92. doi: 10.1186/s13063-016-1220-9.

    PubMed 26888217

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Everolimus, Tacrolimus and Cyclosporin A in people with Kidney Transplantation and Renal Transplantation, run by Novartis Pharmaceuticals at 27 sites in 2 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 4 inclusion and 15 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 1 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 27 sites in Germany, France. 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 1 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?

Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens (time frame: One year post transplant). 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 NCT01843348, which also lists 2 linked publications.

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 1 May 2017.

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