Trial · NCT01410448
Everolimus in de Novo Kidney Transplant Recipients
NCT01410448, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Everolimus in de Novo Kidney Transplant Recipients. Trials, record NCT01410448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01410448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Everolimus in de Novo Kidney Transplant Recipients
- NCT number
- NCT01410448
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 383 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Kidney Transplantation
- Interventions
- Everolimus, Mycophenolate sodium, Cyclosporine, Steroids
- First posted
- 2011-08-05
- Last updated
- 2017-06-16
- Other registries' IDs
- eudract:2011-002866-19
- Results first posted
- 2017-06-16
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 3 months | The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason. |
| Secondary | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 12 months | The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit. |
| Secondary | Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | 3 months | The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason. |
| Secondary | Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | 3 Months, 12 months | The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason. |
| Secondary | Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | 3 months | The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason. |
| Secondary | Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario | 3 months, 12 months | The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason. |
| Secondary | Percentage of Participants With BPAR - Worst-case Scenario | 3 Months, 12 months | A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason. |
| Secondary | Percentage of Participants With Delayed Graft Function (DGF) - | 3 Months | DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation. |
| Secondary | Duration of DGF | 3 months | The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT | baseline, 3 Months | Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3\*(serum creatinine \[mg/dL\])\^-1.154 \* (age at screening) -0.203 \* (0.742 if female) \* (1.21 if African American). A positive change from baseline indicates improvement. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 3 months | The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | 12 months | The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | 3 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | 3 Months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | 3 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario | 3 months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With BPAR - Worst-case Scenario | 3 Months, 12 months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Delayed Graft Function (DGF) - | 3 Months | The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Duration of DGF | 3 months | Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated. | Days | MEDIAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT | baseline, 3 Months | Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated. | mL/min | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | Immediate Everolimus (IE) | 68.39 | Percentage of participants | ||
| Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | Delayed Everolimus (DE) | 61.58 | Percentage of participants | ||
| Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | Immediate Everolimus (IE) | 65.80 | Percentage of participants | ||
| Percentage of Participants Without Wound Healing Complications - Worst-case Scenario | Delayed Everolimus (DE) | 59.47 | Percentage of participants | ||
| Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | Immediate Everolimus (IE) | 11.40 | Percentage of participants | ||
| Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario | Delayed Everolimus (DE) | 21.05 | Percentage of participants | ||
| Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | Immediate Everolimus (IE) | 6.22 | Percentage of participants | ||
| Patient Survival Rate: Percentage of Deaths - Worst-case Scenario | Delayed Everolimus (DE) | 18.42 | Percentage of participants | ||
| Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | Immediate Everolimus (IE) | 6.74 | Percentage of participants | ||
| Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario | Delayed Everolimus (DE) | 18.42 | Percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immediate Everolimus (IE) | 193 | |
| Overall Study | STARTED | Delayed Everolimus (DE) | 190 | |
| Overall Study | Intent-to Treat (ITT) Analysis Set | Immediate Everolimus (IE) | 193 | |
| Overall Study | Intent-to Treat (ITT) Analysis Set | Delayed Everolimus (DE) | 190 | |
| Overall Study | Modified ITT Analysis Set | Immediate Everolimus (IE) | 161 | |
| Overall Study | Modified ITT Analysis Set | Delayed Everolimus (DE) | 149 | |
| Overall Study | COMPLETED | Immediate Everolimus (IE) | 181 | |
| Overall Study | COMPLETED | Delayed Everolimus (DE) | 155 | |
| Overall Study | NOT COMPLETED | Immediate Everolimus (IE) | 12 | |
| Overall Study | NOT COMPLETED | Delayed Everolimus (DE) | 35 |
Source ClinicalTrials.gov
Adverse events278
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 | Immediate Everolimus (IE) | 67 | 193 | |
| other | Anaemia | Blood and lymphatic system disorders | Delayed Everolimus (DE) | 58 | 190 | |
| other | Leukopenia | Blood and lymphatic system disorders | Immediate Everolimus (IE) | 8 | 193 | |
| other | Leukopenia | Blood and lymphatic system disorders | Delayed Everolimus (DE) | 14 | 190 | |
| other | Abdominal pain | Gastrointestinal disorders | Immediate Everolimus (IE) | 14 | 193 | |
| other | Abdominal pain | Gastrointestinal disorders | Delayed Everolimus (DE) | 15 | 190 | |
| other | Constipation | Gastrointestinal disorders | Immediate Everolimus (IE) | 12 | 193 | |
| other | Constipation | Gastrointestinal disorders | Delayed Everolimus (DE) | 13 | 190 | |
| other | Nausea | Gastrointestinal disorders | Immediate Everolimus (IE) | 4 | 193 | |
| other | Nausea | Gastrointestinal disorders | Delayed Everolimus (DE) | 14 | 190 |
1 to 10 of 278Source ClinicalTrials.gov
See all 278 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immediate Everolimus (IE) | ||
| Total, all-cause mortality | Delayed Everolimus (DE) | ||
| Total, other adverse events | Immediate Everolimus (IE) | 155 | 193 |
| Total, other adverse events | Delayed Everolimus (DE) | 156 | 190 |
| Total, serious adverse events | Immediate Everolimus (IE) | 73 | 193 |
| Total, serious adverse events | Delayed Everolimus (DE) | 61 | 190 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Immediate Everolimus (IE) vs Delayed Everolimus (DE): serious adverse events |
Source Trial comparisons
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/NCT01410448
GET https://conductscience.org/api/trials/v1/NCT01410448/results?page=2