Trial · NCT00048165
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
NCT00048165, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation. Trials, record NCT00048165. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048165
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
- NCT number
- NCT00048165
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 434 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Heart Transplantation
- Interventions
- Daclizumab, Methylprednisolone, Mycophenolate mofetil, Placebo, cyclosporine
- First posted
- 2002-10-25
- Last updated
- 2016-06-13
- Results first posted
- 2016-06-13
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | Up to 6 months PT | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up. |
| Secondary | Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | Up to 12 months PT | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up |
| Secondary | Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first. |
| Secondary | Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT | At 6 months, 12 months , 3 years PT | The survival of the graft and participants at 6,12 months and 3 years PT was reported |
| Secondary | Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis |
| Secondary | Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The median time to first acute rejection episode within first 6 months and 12 months PT was reported. |
| Secondary | Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported. |
| Secondary | Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT | Within 6 months and 12 months PT | The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral \[PO\]/nasogastric \[NG\] within 72 hours post-operative\]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval. |
| Secondary | Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides) | From Baseline (Day -2) to 3 months and 6 months | Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre \[mg/dL\]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported. |
| Secondary | Median Change From Baseline for LDL/HDL Ratio | From Baseline (Day -2) to 3 months, and 6 months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | Up to 6 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | Up to 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT | At 6 months, 12 months , 3 years PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'. | days | MEDIAN |
| SECONDARY | Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT | Within 6 months and 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | participants | NUMBER |
| SECONDARY | Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT | Within 6 months and 12 months PT | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'. | mg | MEAN |
| SECONDARY | Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides) | From Baseline (Day -2) to 3 months and 6 months | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'. | mg/dL | MEDIAN |
| SECONDARY | Median Change From Baseline for LDL/HDL Ratio | From Baseline (Day -2) to 3 months, and 6 months | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | ratio | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | Daclizumab | 77 | participants | ||
| Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | Placebo | 104 | participants | ||
| Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | Daclizumab | 97 | participants | ||
| Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | Placebo | 116 | participants | ||
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Daclizumab | Within 6 months, 0 episode | 139 | participants | |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Placebo | Within 6 months, 0 episode | 114 | participants | |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Daclizumab | Within 6 months, 1 episode | 63 | participants | |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Placebo | Within 6 months, 1 episode | 82 | participants | |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Daclizumab | Within 6 months, 2 episodes | 12 | participants | |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | Placebo | Within 6 months, 2 episodes | 19 | participants |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed 6 Months Study | STARTED | Daclizumab | 216 | |
| Completed 6 Months Study | STARTED | Placebo | 218 | |
| Completed 6 Months Study | COMPLETED | Daclizumab | 165 | |
| Completed 6 Months Study | COMPLETED | Placebo | 170 | |
| Completed 6 Months Study | NOT COMPLETED | Daclizumab | 51 | |
| Completed 6 Months Study | NOT COMPLETED | Placebo | 48 | |
| Completed 12 Months Study | STARTED | Daclizumab | 165 | |
| Completed 12 Months Study | STARTED | Placebo | 170 | |
| Completed 12 Months Study | COMPLETED | Daclizumab | 162 | |
| Completed 12 Months Study | COMPLETED | Placebo | 167 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events512
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 nos | Blood and lymphatic system disorders | Daclizumab | 64 | 216 | |
| other | Anaemia nos | Blood and lymphatic system disorders | Placebo | 52 | 207 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Daclizumab | 15 | 216 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 16 | 207 | |
| other | Leukopenia nos | Blood and lymphatic system disorders | Daclizumab | 32 | 216 | |
| other | Leukopenia nos | Blood and lymphatic system disorders | Placebo | 22 | 207 | |
| other | Neutropenia | Blood and lymphatic system disorders | Daclizumab | 17 | 216 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 11 | 207 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Daclizumab | 22 | 216 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 26 | 207 |
1 to 10 of 512Source ClinicalTrials.gov
See all 512 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daclizumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Daclizumab | 210 | 216 |
| Total, other adverse events | Placebo | 204 | 207 |
| Total, serious adverse events | Daclizumab | 108 | 216 |
| Total, serious adverse events | Placebo | 102 | 207 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Daclizumab vs Placebo: Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | Trial comparisons |
| Daclizumab vs Placebo: Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | Trial comparisons |
| Daclizumab vs Placebo: serious adverse events | 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/NCT00048165
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