Phase 3
Completed N=612
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
Chronic Kidney Disease · Renal Transplantation
Source: ClinicalTrials.gov NCT01843348 ↗
Enrolled (actual)
612
Serious AEs
71.9%
Results posted
May 2017
Primary outcomePrimary: Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens — 62.62; 60.54; 59.47; 66.36 mL/min per 1.73m² — p=<0.0001
◆ Published Evidence
Emerging
13citations · ~1 / year
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.
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.
Linked Publications (2)
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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.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens |
62.62; 60.54; 59.47; 66.36; 61.21; 62.22 | <0.0001 sig |
| SECONDARY Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12 |
9.8; 13.0; 24.6; 3.2; 14.9; 15.6 | — |
| SECONDARY Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant |
51.62; 44.42; 42.44 | — |
| SECONDARY Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant |
60.26; 52.25; 51.30 | — |
| SECONDARY Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant |
53.24; 45.72; 43.47 | — |
| SECONDARY Percentage of Participants With Treatment Failure Endpoints at Month 12 |
9.3; 12.0; 24.6; 8.8; 11.5; 23.6 | < 0.001 sig |
| SECONDARY Percent of Participants With Delayed Graft Function and Slow Graft Function |
17.8; 20.3; 22.1; 46.2; 48.7; 49.7 | — |
| SECONDARY Percent of Participants With Delayed Graft Function by Day |
22.9; 18.4; 10.5; 5.7; 5.3; 5.3 | — |
| SECONDARY Percent of Participants With Viral Infections |
1.0; 0.0; 1.0; 7.0; 1.0; 1.0 | — |
| SECONDARY Percent of Participants With Wound Healing Complications During Study |
14.3; 19.1; 22.2; 18.7; 26.8; 27.8 | — |
| SECONDARY Duration of Wound Healing |
42.4; 54.1; 85.3 | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT01843348) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.