Trial · NCT00622869
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
NCT00622869, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients. Trials, record NCT00622869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00622869
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
- NCT number
- NCT00622869
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 719 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Liver Transplantation
- Interventions
- Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control), Everolimus (reduced tacrolimus), Everolimus (tacrolimus elimination), Corticosteroids
- First posted
- 2008-02-25
- Last updated
- 2013-05-27
- Other registries' IDs
- eudract:2007-001821-85
- Results first posted
- 2013-05-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 | Randomization to Month 12 | Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died. The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula. |
| Secondary | Incidence Rate of Composite Efficacy Failure From Randomization to Month 24 | Randomization to Month 24 | Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. The incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula. |
| Secondary | Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Randomization to Month 24 | tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died. The incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula. |
| Secondary | Change in Renal Function From Randomization to Months 12 and 24 | Randomization to Month 24 | Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m\^2) = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1. The changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 | Randomization to Month 12 | Intent-to-treat population: All randomized patients. | Percentage of participants | NUMBER |
| SECONDARY | Incidence Rate of Composite Efficacy Failure From Randomization to Month 24 | Randomization to Month 24 | Intent-to-treat population: All randomized patients. | Percentage | NUMBER |
| SECONDARY | Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Randomization to Month 24 | Intent-to-treat population: All randomized patients. | Percentage | NUMBER |
| SECONDARY | Change in Renal Function From Randomization to Months 12 and 24 | Randomization to Month 24 | Intent-to-treat population: All randomized patients. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 | Everolimus + Reduced Tacrolimus | 6.7 | Percentage of participants | ||
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 | Tacrolimus Elimination | 24.2 | Percentage of participants | ||
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 12 | Tacrolimus Control Arm | 9.7 | Percentage of participants | ||
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 24 | Everolimus + Reduced Tacrolimus | 10.3 | Percentage | ||
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 24 | Tacrolimus Elimination | 26.0 | Percentage | ||
| Incidence Rate of Composite Efficacy Failure From Randomization to Month 24 | Tacrolimus Control Arm | 12.5 | Percentage | ||
| Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Everolimus + Reduced Tacrolimus | Month 12 | 3.0 | Percentage | |
| Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Tacrolimus Elimination | Month 12 | 18.8 | Percentage | |
| Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Tacrolimus Control Arm | Month 12 | 7.2 | Percentage | |
| Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24 | Everolimus + Reduced Tacrolimus | Month 24 | 4.8 | Percentage |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus + Reduced Tacrolimus | 245 | |
| Overall Study | STARTED | Tacrolimus Elimination | 231 | |
| Overall Study | STARTED | Tacrolimus Control Arm | 243 | |
| Overall Study | COMPLETED | Everolimus + Reduced Tacrolimus | 202 | |
| Overall Study | COMPLETED | Tacrolimus Elimination | 174 | |
| Overall Study | COMPLETED | Tacrolimus Control Arm | 204 | |
| Overall Study | NOT COMPLETED | Everolimus + Reduced Tacrolimus | 43 | |
| Overall Study | NOT COMPLETED | Tacrolimus Elimination | 57 | |
| Overall Study | NOT COMPLETED | Tacrolimus Control Arm | 39 |
Source ClinicalTrials.gov
Adverse events1,464
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 | Everolimus + Reduced Tacrolimus | 22 | 245 | |
| other | Anaemia | Blood and lymphatic system disorders | Tacrolimus Elimination | 26 | 229 | |
| other | Anaemia | Blood and lymphatic system disorders | Tacrolimus Control Arm | 20 | 242 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus + Reduced Tacrolimus | 31 | 245 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tacrolimus Elimination | 23 | 229 | |
| other | Leukopenia | Blood and lymphatic system disorders | Tacrolimus Control Arm | 12 | 242 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus + Reduced Tacrolimus | 16 | 245 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tacrolimus Elimination | 17 | 229 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tacrolimus Control Arm | 5 | 242 | |
| other | Abdominal pain | Gastrointestinal disorders | Everolimus + Reduced Tacrolimus | 35 | 245 |
1 to 10 of 1,464Source ClinicalTrials.gov
See all 1,464 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus + Reduced Tacrolimus | ||
| Total, all-cause mortality | Tacrolimus Elimination | ||
| Total, all-cause mortality | Tacrolimus Control Arm | ||
| Total, other adverse events | Everolimus + Reduced Tacrolimus | 218 | 245 |
| Total, other adverse events | Tacrolimus Elimination | 194 | 229 |
| Total, other adverse events | Tacrolimus Control Arm | 205 | 242 |
| Total, serious adverse events | Everolimus + Reduced Tacrolimus | 138 | 245 |
| Total, serious adverse events | Tacrolimus Elimination | 152 | 229 |
| Total, serious adverse events | Tacrolimus Control Arm | 131 | 242 |
Source ClinicalTrials.gov
Papers3
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/NCT00622869
GET https://conductscience.org/api/trials/v1/NCT00622869/events?page=2