Trial · NCT00377962
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
NCT00377962, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2011-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation. Trials, record NCT00377962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377962
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
- NCT number
- NCT00377962
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 282 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Disorder Related to Cardiac Transplantation
- Interventions
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI), Steroids
- First posted
- 2006-09-19
- Last updated
- 2020-07-30
- Results first posted
- 2011-04-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Baseline to Month 12 | Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function. |
| Secondary | Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Baseline to end of study (Month 24) | Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function. |
| Secondary | Change in Serum Creatinine From Baseline to End of Study (Month 24) | Baseline to end of study (Month 24) | Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function. |
| Secondary | Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart \& Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy. |
| Secondary | Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | Number of patients not alive and number of patients with loss of their graft. |
| Secondary | Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | |
| Secondary | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup | Baseline to end of study (Month 24) | Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function. |
| Secondary | Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup | Baseline to end of study (Month 24) | Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function. |
| Secondary | Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup | Baseline to end of study (Month 24) | Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function. |
| Secondary | Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup | Baseline to end of study (Month 24) | Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Baseline to Month 12 | Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | mL/min | MEAN |
| SECONDARY | Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Baseline to end of study (Month 24) | Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | mL/min | MEAN |
| SECONDARY | Change in Serum Creatinine From Baseline to End of Study (Month 24) | Baseline to end of study (Month 24) | Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | μmol/L | MEAN |
| SECONDARY | Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | Participants | NUMBER |
| SECONDARY | Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | Participants | NUMBER |
| SECONDARY | Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24) | Month 12 to end of study (Month 24) | The intent-to-treat (ITT) population consisted of all patients as randomized, who were given at least one dose of study drug and had at least one post-baseline assessment. (Extension study) | Participants | NUMBER |
| SECONDARY | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup | Baseline to end of study (Month 24) | Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | Liters | MEAN |
| SECONDARY | Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup | Baseline to end of study (Month 24) | Patients in the lung transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | Liters | MEAN |
| SECONDARY | Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup | Baseline to end of study (Month 24) | Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | cm | MEAN |
| SECONDARY | Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup | Baseline to end of study (Month 24) | Patients in the heart transplant subgroup of the intent-to-treat (ITT) population which included all randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment. | percentage | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Everolimus + CNI Reduction | Baseline | 48.6 | Standard Deviation 15.1 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Control | Baseline | 48.0 | Standard Deviation 13.2 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Everolimus + CNI Reduction | Month 12 | 53.2 | Standard Deviation 15.7 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Control | Month 12 | 47.5 | Standard Deviation 16.1 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Everolimus + CNI Reduction | Change from Baseline | 4.6 | Standard Deviation 10.4 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 | Control | Change from Baseline | -0.5 | Standard Deviation 9.0 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Everolimus + CNI Reduction | Month 0 | 49.3 | Standard Deviation 14.7 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Control | Month 0 | 49.1 | Standard Deviation 13.0 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Everolimus + CNI Reduction | Month 24 | 52.5 | Standard Deviation 16.4 | mL/min |
| Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24) | Control | Month 24 | 46.8 | Standard Deviation 15.2 | mL/min |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study: 0-12 Months | STARTED | Everolimus + CNI Reduction | 140 | |
| Core Study: 0-12 Months | STARTED | Control | 142 | |
| Core Study: 0-12 Months | COMPLETED | Everolimus + CNI Reduction | 112 | |
| Core Study: 0-12 Months | COMPLETED | Control | 133 | |
| Core Study: 0-12 Months | NOT COMPLETED | Everolimus + CNI Reduction | 28 | |
| Core Study: 0-12 Months | NOT COMPLETED | Control | 9 | |
| Extension Study: 12-24 Months | STARTED | Everolimus + CNI Reduction | 108 | |
| Extension Study: 12-24 Months | STARTED | Control | 127 | |
| Extension Study: 12-24 Months | COMPLETED | Everolimus + CNI Reduction | 98 | |
| Extension Study: 12-24 Months | COMPLETED | Control | 123 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,544
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 | Leucopenia NOS | Blood and lymphatic system disorders | Control: 12 Month Heart | 0 | 96 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Everolimus + CNI Reduction: 12 Month Heart | 8 | 94 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Control: 12 Month Lung | 0 | 46 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Everolimus+CNI Reduction: 12 Month Lung | 8 | 46 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Control: 24 Month Heart | 1 | 86 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Everolimus + CNI Reduction: 24 Month Heart | 1 | 69 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Control: 24 Month Lung | 0 | 41 | |
| other | Leucopenia NOS | Blood and lymphatic system disorders | Everolimus + CNI Reduction: 24 Month Lung | 1 | 39 | |
| other | Oedema NOS | Cardiac disorders | Control: 12 Month Heart | 10 | 96 | |
| other | Oedema NOS | Cardiac disorders | Everolimus + CNI Reduction: 12 Month Heart | 24 | 94 |
1 to 10 of 1,544Source ClinicalTrials.gov
See all 1,544 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control: 12 Month Heart | ||
| Total, all-cause mortality | Everolimus + CNI Reduction: 12 Month Heart | ||
| Total, all-cause mortality | Control: 12 Month Lung | ||
| Total, all-cause mortality | Everolimus+CNI Reduction: 12 Month Lung | ||
| Total, all-cause mortality | Control: 24 Month Heart | ||
| Total, all-cause mortality | Everolimus + CNI Reduction: 24 Month Heart | ||
| Total, all-cause mortality | Control: 24 Month Lung | ||
| Total, all-cause mortality | Everolimus + CNI Reduction: 24 Month Lung | ||
| Total, other adverse events | Control: 12 Month Heart | 48 | 96 |
| Total, other adverse events | Everolimus + CNI Reduction: 12 Month Heart | 75 | 94 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers4
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Everolimus + CNI Reduction vs Control: Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24) | Trial comparisons |
| Everolimus + CNI Reduction vs Control: Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24) | 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/NCT00377962
GET https://conductscience.org/api/trials/v1/NCT00377962/results?page=2