Trial · NCT02115113
REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
NCT02115113, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy. Trials, record NCT02115113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02115113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy
- NCT number
- NCT02115113
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 78 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Liver Transplantation
- Interventions
- Everolimus, Tacrolimus
- First posted
- 2014-04-15
- Last updated
- 2019-02-28
- Other registries' IDs
- eudract:2013-004325-91
- Results first posted
- 2019-02-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR) | At 12 months post-transplant | Renal function was assessed by eGFR using the MDRD-4 formula at 12 months after transplant: eGFR = 186.3 \* (serum creatinine)-1.154 \* age-0.203 \* (0.742 for women) \* (1.21 if African American) where serum creatinine was in mg/dL and age in years. |
| Secondary | Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | At 12 and 18 months post-transplant | Participants were assessed for tBPAR, AR, GL or death. For all suspected rejection episodes, regardless of initiation of anti-rejection treatment, a liver biopsy was to be performed preferably within 24 hours, latest within 48 hours whenever clinically possible. A treated biopsy proven acute rejection was considered an episode of acute rejection when demonstrated by local pathology reading with a rejection activity index of at least 3 or greater of acute rejection index and when treated with anti-rejection therapy. The allograft was considered lost on the day the subject was re-transplanted or died due to liver failure. |
| Secondary | Change From Baseline (Randomization) in Serum Creatinine at 12 Months Post-transplant | baseline, 12 months post-transplant | Blood samples were collected to assess serum creatinine. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR) | At 12 months post-transplant | The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis. eGFR values missing at 12 months post transplantation were imputed using the Last Observation carried Forward (LOCF) approach. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | At 12 and 18 months post-transplant | The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (Randomization) in Serum Creatinine at 12 Months Post-transplant | baseline, 12 months post-transplant | The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis. | mg/dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR) | Group A (Tacrolimus Elimination Arm) | 85.50 | Standard Error 3.97 | mL/min/1.73m^2 | |
| Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR) | Group B (Tacrolimus Minimization Arm) | 80.26 | Standard Error 3.87 | mL/min/1.73m^2 | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group A (Tacrolimus Elimination Arm) | tBPAR, 12 months | 2 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group B (Tacrolimus Minimization Arm) | tBPAR, 12 months | 1 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group A (Tacrolimus Elimination Arm) | AR, 12 months | 2 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group B (Tacrolimus Minimization Arm) | AR, 12 months | 1 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group A (Tacrolimus Elimination Arm) | GL, 12 months | 0 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group B (Tacrolimus Minimization Arm) | GL, 12 months | 0 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group A (Tacrolimus Elimination Arm) | Death, 12 months | 1 | Participants | |
| Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D) | Group B (Tacrolimus Minimization Arm) | Death, 12 months | 0 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Participants in Run-in Period | STARTED | Group A (Tacrolimus Elimination Arm) | 0 | |
| Participants in Run-in Period | STARTED | Group B (Tacrolimus Minimization Arm) | 0 | |
| Participants in Run-in Period | STARTED | Total Enrolled at run-in | 78 | |
| Participants in Run-in Period | COMPLETED | Group A (Tacrolimus Elimination Arm) | 0 | |
| Participants in Run-in Period | COMPLETED | Group B (Tacrolimus Minimization Arm) | 0 | |
| Participants in Run-in Period | COMPLETED | Total Enrolled at run-in | 68 | |
| Participants in Run-in Period | NOT COMPLETED | Group A (Tacrolimus Elimination Arm) | 0 | |
| Participants in Run-in Period | NOT COMPLETED | Group B (Tacrolimus Minimization Arm) | 0 | |
| Participants in Run-in Period | NOT COMPLETED | Total Enrolled at run-in | 10 | |
| Participants Randomized | STARTED | Group A (Tacrolimus Elimination Arm) | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events415
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 | Run-in Population Total | 5 | 78 | |
| other | Anaemia | Blood and lymphatic system disorders | Run-in Population Tacrolimus Elimination | 0 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Run-in Population Tacrolimus Minimization | 3 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomization Treatment Period Tacrolimus Elimination | 0 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomization Treatment Period Tacrolimus Minimization | 5 | 26 | |
| other | Leukopenia | Blood and lymphatic system disorders | Run-in Population Total | 6 | 78 | |
| other | Leukopenia | Blood and lymphatic system disorders | Run-in Population Tacrolimus Elimination | 0 | 24 | |
| other | Leukopenia | Blood and lymphatic system disorders | Run-in Population Tacrolimus Minimization | 4 | 26 | |
| other | Leukopenia | Blood and lymphatic system disorders | Randomization Treatment Period Tacrolimus Elimination | 1 | 24 | |
| other | Leukopenia | Blood and lymphatic system disorders | Randomization Treatment Period Tacrolimus Minimization | 2 | 26 |
1 to 10 of 415Source ClinicalTrials.gov
See all 415 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Population Total | ||
| Total, all-cause mortality | Run-in Population Tacrolimus Elimination | ||
| Total, all-cause mortality | Run-in Population Tacrolimus Minimization | ||
| Total, all-cause mortality | Randomization Treatment Period Tacrolimus Elimination | ||
| Total, all-cause mortality | Randomization Treatment Period Tacrolimus Minimization | ||
| Total, other adverse events | Run-in Population Total | 57 | 78 |
| Total, other adverse events | Run-in Population Tacrolimus Elimination | 20 | 24 |
| Total, other adverse events | Run-in Population Tacrolimus Minimization | 21 | 26 |
| Total, other adverse events | Randomization Treatment Period Tacrolimus Elimination | 16 | 24 |
| Total, other adverse events | Randomization Treatment Period Tacrolimus Minimization | 15 | 26 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02115113
GET https://conductscience.org/api/trials/v1/NCT02115113/events?page=2