Trial · NCT00300274
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
NCT00300274, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-08-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection. Trials, record NCT00300274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00300274
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
- NCT number
- NCT00300274
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 721 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Graft Rejection
- Interventions
- everolimus, mycophenolate mofetil, cyclosporine, corticosteroids
- First posted
- 2006-03-08
- Last updated
- 2012-08-16
- Results first posted
- 2012-08-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Composite Efficacy Failure at 12 Months | 12 Months | Composite efficacy failure was defined as Biopsy Proven Acute Rejection(BPAR) of International Society for Heart and Lung Transplantation(ISHLT) grade ≥3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejection was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤30% or 25% lower than Baseline or Fractional shortening ≤20% or 25% lower than Baseline and/or use of inotropic treatment. |
| Secondary | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 12 Months | Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 316 (start day of the Month 12 visit window). |
| Secondary | Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 12 Months | GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 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 |
| Secondary | Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | Baseline, Month 12 | Maximum intimal thickness was assessed using Intravascular Ultrasound (IVUS). IVUS is a technique for taking ultrasound pictures of the wall of an artery from inside the artery itself. It shows the thickness of the artery wall and any narrowing of the artery. |
| Secondary | Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 12 Months | Cardiac allograft vasculopathy is defined as a 0.5 mm increase in maximum intimal thickness as measured by Intravascular Ultrasound (IVUS) in at least one matched slice between baseline and Month 12. |
| Secondary | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | 12 Months | Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/or use of inotropic treatment. |
| Secondary | Percentage of Participants With Composite Efficacy Failure at 24 Months | 24 Months | Composite efficacy failure was defined as Biopsy Proven Acute Rejection (BPAR) of International Society for Heart and Lung Transplantation grade ≥ 3A, Acute Rejection associated with Hemodynamic Compromise, Graft loss/Retransplant, Death or Loss to follow-up. Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline and/or use of inotropic treatment. |
| Secondary | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 24 Months | Loss to follow-up for this composite endpoint included participants who did not experience graft loss/re-transplant or death and whose last day of contact was prior to Day 631 (start day of 24 Month visit window). |
| Secondary | Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 24 Months | GFR was calculated using the Modification of Diet and Renal Disease (MDRD) formula: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R 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 |
| Secondary | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | 24 Months | Identification of acute rejections was based on the local pathologist's evaluation of endomyocardial biopsy slides. Hemodynamic compromise was present if 1 or more of the following were met: Ejection fraction ≤ 30% or 25% lower than Baseline or Fractional shortening ≤ 20% or 25% lower than Baseline, and/ or use of inotropic treatment. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Composite Efficacy Failure at 12 Months | 12 Months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | 12 Months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | 12 Months | Participants from the intent-to-treat population (all randomized participants) with data available for analysis. | mL/min/1.73^2 | MEAN |
| SECONDARY | Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | Baseline, Month 12 | IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS Centers). | mm | MEAN |
| SECONDARY | Percentage of Participants With Cardiac Allograft Vasculopathy (CAV) at Month 12 | 12 Months | IVUS population consisted of randomized patients who had a minimum of 11 matched slices between IVUS images from Baseline and from Month 12 (IVUS centers). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 12 | 12 Months | Intent-to-treat population includes all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Composite Efficacy Failure at 24 Months | 24 Months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 24 Months | 24 Months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Renal Function Calculated by Glomerular Filtration Rate (GFR) at 24 Months | 24 Months | Participants from the intent-to-treat population (all randomized participants) with data available for analysis. | mL/min/1.73^2 | MEAN |
| SECONDARY | Percentage of Participants With Biopsy-proven Acute Rejection (BPAR of ISHLT Grade ≥ 3A), Acute Rejection (AR) Associated With Hemodynamic Compromise (HDC), Graft Loss/Re-transplant and Death at Month 24 | 24 Months | Intent-to-treat population included all randomized participants. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Composite Efficacy Failure at 12 Months | Everolimus 1.5 mg | 35.1 | Percentage of participants | ||
| Percentage of Participants With Composite Efficacy Failure at 12 Months | Everolimus 3.0 mg | 35.1 | Percentage of participants | ||
| Percentage of Participants With Composite Efficacy Failure at 12 Months | Mycophenolate Mofetil | 33.6 | Percentage of participants | ||
| Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | Everolimus 1.5 mg | 11.7 | Percentage of participants | ||
| Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | Everolimus 3.0 mg | 11.9 | Percentage of participants | ||
| Percentage of Participants With Graft Loss/Re-transplant, Death or Loss to Follow-up at 12 Months | Mycophenolate Mofetil | 8.9 | Percentage of participants | ||
| Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | Everolimus 1.5 mg | 59.21 | Standard Deviation 23.113 | mL/min/1.73^2 | |
| Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | Everolimus 3.0 mg | 59.78 | Standard Deviation 23.141 | mL/min/1.73^2 | |
| Renal Function Measured by Glomerular Filtration Rate (GFR) at 12 Months | Mycophenolate Mofetil | 64.37 | Standard Deviation 28.365 | mL/min/1.73^2 | |
| Change From Baseline in the Average Maximum Intimal Thickness at Month 12 | Everolimus 1.5 mg | 0.03 | Standard Deviation 0.052 | mm |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus 1.5 mg | 282 | |
| Overall Study | STARTED | Everolimus 3.0 mg | 168 | |
| Overall Study | STARTED | Mycophenolate Mofetil | 271 | |
| Overall Study | Completed 12 Month | Everolimus 1.5 mg | 250 | |
| Overall Study | Completed 12 Month | Everolimus 3.0 mg | 149 | |
| Overall Study | Completed 12 Month | Mycophenolate Mofetil | 248 | |
| Overall Study | COMPLETED | Everolimus 1.5 mg | 236 | |
| Overall Study | COMPLETED | Everolimus 3.0 mg | 141 | |
| Overall Study | COMPLETED | Mycophenolate Mofetil | 226 | |
| Overall Study | NOT COMPLETED | Everolimus 1.5 mg | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,797
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 1.5 mg | 105 | 279 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus 3.0 mg | 60 | 167 | |
| other | Anaemia | Blood and lymphatic system disorders | Mycophenolate Mofetil | 74 | 268 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Everolimus 1.5 mg | 37 | 279 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Everolimus 3.0 mg | 27 | 167 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Mycophenolate Mofetil | 27 | 268 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus 1.5 mg | 36 | 279 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus 3.0 mg | 29 | 167 | |
| other | Leukopenia | Blood and lymphatic system disorders | Mycophenolate Mofetil | 67 | 268 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus 1.5 mg | 8 | 279 |
1 to 10 of 1,797Source ClinicalTrials.gov
See all 1,797 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus 1.5 mg | ||
| Total, all-cause mortality | Everolimus 3.0 mg | ||
| Total, all-cause mortality | Mycophenolate Mofetil | ||
| Total, other adverse events | Everolimus 1.5 mg | 275 | 279 |
| Total, other adverse events | Everolimus 3.0 mg | 165 | 167 |
| Total, other adverse events | Mycophenolate Mofetil | 262 | 268 |
| Total, serious adverse events | Everolimus 1.5 mg | 209 | 279 |
| Total, serious adverse events | Everolimus 3.0 mg | 119 | 167 |
| Total, serious adverse events | Mycophenolate Mofetil | 168 | 268 |
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 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/NCT00300274
GET https://conductscience.org/api/trials/v1/NCT00300274/results?page=2