Clinical trial NCT01843348: 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Renal Transplantation
Keywords: Transplant
Renal transplant
Rejection,allograf
Rejection
Xenograft rejection
Host vs graft disease
Kidney Transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

--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
* 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

Primary outcomes:
measure: Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens
timeFrame: One year post transplant
Secondary outcomes:
measure: Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12
timeFrame: Month 12 post transplant
measure: Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant
timeFrame: Month 12 post transplant
measure: Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant
timeFrame: Month 12 post transplant
measure: Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant
timeFrame: Month 12 post transplant
measure: Percentage of Participants With Treatment Failure Endpoints at Month 12
timeFrame: Month 12 post transplant
measure: Percent of Participants With Delayed Graft Function and Slow Graft Function
timeFrame: Post transplant to month 12
measure: Percent of Participants With Delayed Graft Function by Day
timeFrame: Post transplant up to day 7
measure: Percent of Participants With Viral Infections
timeFrame: Post transplant to month 12
measure: Percent of Participants With Wound Healing Complications During Study
timeFrame: Post transplant until individual reporting
measure: Duration of Wound Healing
timeFrame: Post transplant until individual reporting
Other outcomes:
Locations:
city: Bordeaux Cedex
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: St Priest en Jarez Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex 4
country: France
facility: Novartis Investigative Site
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.