Trial · NCT01843348
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
NCT01843348, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients. Trials, record NCT01843348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01843348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
- NCT number
- NCT01843348
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 612 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Kidney Transplantation, Renal Transplantation
- Interventions
- Everolimus, Tacrolimus, Cyclosporin A, Enteric Coated Mycophenolate Sodium (EC-MPS), Mycophenolate mofetil (MMF), Corticosteroids, Simulect
- First posted
- 2013-04-30
- Last updated
- 2017-05-01
- Other registries' IDs
- eudract:2011-005238-21
- Results first posted
- 2017-05-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | One year post transplant | 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 |
| Secondary | Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12 | Month 12 post transplant | 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) |
| Secondary | Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant | 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 |
| Secondary | Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant | 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 |
| Secondary | Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant | 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 |
| Secondary | Percentage of Participants With Treatment Failure Endpoints at Month 12 | Month 12 post transplant | 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) |
| Secondary | Percent of Participants With Delayed Graft Function and Slow Graft Function | Post transplant to month 12 | 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 |
| Secondary | Percent of Participants With Delayed Graft Function by Day | Post transplant up to day 7 | Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. |
| Secondary | Percent of Participants With Viral Infections | Post transplant to month 12 | Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus |
| Secondary | Percent of Participants With Wound Healing Complications During Study | Post transplant until individual reporting | Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | One year post transplant | Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons | mL/min per 1.73m² | MEAN |
| SECONDARY | Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12 | Month 12 post transplant | Full analysis set includes all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant | Month 12 post transplant | Full analysis set | mL/min per 1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant | Month 12 post transplant | Full analysis set | mL/min per 1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant | Month 12 post transplant | Full analysis set | mL/min per 1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Treatment Failure Endpoints at Month 12 | Month 12 post transplant | Percentage of participants | NUMBER | |
| SECONDARY | Percent of Participants With Delayed Graft Function and Slow Graft Function | Post transplant to month 12 | Full analysis set | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With Delayed Graft Function by Day | Post transplant up to day 7 | Full analysis set | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With Viral Infections | Post transplant to month 12 | Safety set | Percent of participants | NUMBER |
| SECONDARY | Percent of Participants With Wound Healing Complications During Study | Post transplant until individual reporting | Percent of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+MPA | Month 1 - Day 1 to 60 (146,111,78) | 62.62 | Standard Deviation 16.931 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+Certican | Month 1 - Day 1 to 60 (146,111,78) | 60.54 | Standard Deviation 17.310 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | CycA+Certican | Month 1 - Day 1 to 60 (146,111,78) | 59.47 | Standard Deviation 16.754 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+MPA | Month 3 - Day 61 to 136 (143,108,79) | 66.36 | Standard Deviation 16.672 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+Certican | Month 3 - Day 61 to 136 (143,108,79) | 61.21 | Standard Deviation 14.771 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | CycA+Certican | Month 3 - Day 61 to 136 (143,108,79) | 62.22 | Standard Deviation 16.196 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+MPA | Month 6 - Day 137 to 228 (142,108,76) | 68.05 | Standard Deviation 16.994 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+Certican | Month 6 - Day 137 to 228 (142,108,76) | 62.76 | Standard Deviation 16.763 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | CycA+Certican | Month 6 - Day 137 to 228 (142,108,76) | 63.17 | Standard Deviation 16.789 | mL/min per 1.73m² |
| Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens | TAC+MPA | Month 9 - Day 229 to 319 (140,106,77) | 69.47 | Standard Deviation 16.251 | mL/min per 1.73m² |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAC+MPA | 205 | |
| Overall Study | STARTED | TAC+Certican | 208 | |
| Overall Study | STARTED | CycA+Certican | 199 | |
| Overall Study | Safety Analysis Set (SAS) | TAC+MPA | 204 | |
| Overall Study | Safety Analysis Set (SAS) | TAC+Certican | 210 | |
| Overall Study | Safety Analysis Set (SAS) | CycA+Certican | 198 | |
| Overall Study | Full Analysis Set (FAS) | TAC+MPA | 205 | |
| Overall Study | Full Analysis Set (FAS) | TAC+Certican | 208 | |
| Overall Study | Full Analysis Set (FAS) | CycA+Certican | 199 | |
| Overall Study | Per Protocol Set (PPS) | TAC+MPA | 147 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,263
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tac+MPA | 44 | 204 | |
| other | Anaemia | Blood and lymphatic system disorders | Tac+Certican | 53 | 210 | |
| other | Anaemia | Blood and lymphatic system disorders | CycA+Certican | 58 | 198 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tac+MPA | 34 | 204 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tac+Certican | 17 | 210 | |
| other | Leukopenia | Blood and lymphatic system disorders | CycA+Certican | 11 | 198 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tac+MPA | 8 | 204 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tac+Certican | 20 | 210 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CycA+Certican | 20 | 198 | |
| other | Tachycardia | Cardiac disorders | Tac+MPA | 14 | 204 |
1 to 10 of 1,263Source ClinicalTrials.gov
See all 1,263 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tac+MPA | ||
| Total, all-cause mortality | Tac+Certican | ||
| Total, all-cause mortality | CycA+Certican | ||
| Total, other adverse events | Tac+MPA | 200 | 204 |
| Total, other adverse events | Tac+Certican | 205 | 210 |
| Total, other adverse events | CycA+Certican | 196 | 198 |
| Total, serious adverse events | Tac+MPA | 135 | 204 |
| Total, serious adverse events | Tac+Certican | 161 | 210 |
| Total, serious adverse events | CycA+Certican | 144 | 198 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01843348
GET https://conductscience.org/api/trials/v1/NCT01843348/results?page=2