Trial · NCT00113269
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
NCT00113269, Phase 4, Completed, Astellas Pharma Inc; results first posted 2011-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients. Trials, record NCT00113269. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00113269
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
- NCT number
- NCT00113269
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 501 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Kidney Transplantation
- Interventions
- basiliximab, rabbit anti-thymocyte globulin, tacrolimus, alemtuzumab, mycophenolate mofetil, steroids
- First posted
- 2005-06-08
- Last updated
- 2011-08-11
- Results first posted
- 2011-07-08
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 6 months | A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \& Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st. |
| Secondary | Overall Patient Incidence of BCAR | End of Study (36 months) | Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A \& 1B) to Moderate (2A \& 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Efficacy Failure | End of Study (36 months) | Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Clinically Treated Acute Rejection | End of Study (36 months) | Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Time to First BCAR | End of Study (36 months) | Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Graft Survival at 12 Months | 12 months | Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
| Secondary | Overall Graft Survival | End of Study (36 months) | Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Patient Survival at 12 Months | 12 months | Patient survival is defined as not dead within 12 months after skin closure. Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first. |
| Secondary | Overall Patient Survival | End of Study (36 months) | Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival. End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months. |
| Secondary | Renal Function Abnormalities Based on Creatinine Clearance | 1 month and End of Study (36 months) | Increases in creatinine clearance usually indicates an improvement. Change in creatinine clearance from month 1 was calculated. Change from 1 month is calculated by month 36 - month 1. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | 6 months | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Overall Patient Incidence of BCAR | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Efficacy Failure | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Clinically Treated Acute Rejection | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Time to First BCAR | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.~Only patients who experienced BCAR were included in the analysis. | Days | MEDIAN |
| SECONDARY | Graft Survival at 12 Months | 12 months | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Overall Graft Survival | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Patient Survival at 12 Months | 12 months | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Overall Patient Survival | End of Study (36 months) | The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. | Percentage of Patients | NUMBER |
| SECONDARY | Renal Function Abnormalities Based on Creatinine Clearance | 1 month and End of Study (36 months) | The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as N. | mL/s | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | Alemtuzumab High-Risk Patients | 6.2 | 95% Confidence Interval 0.3 to 12.0 | Percentage of Patients | |
| Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | Conventional High-Risk Patients | 9.4 | 95% Confidence Interval 2.2 to 16.7 | Percentage of Patients | |
| Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | Alemtuzumab Low- Risk Patients | 1.9 | 95% Confidence Interval 0.0 to 4.0 | Percentage of Patients | |
| Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months | Conventional Low-Risk Patients | 17.5 | 95% Confidence Interval 11.7 to 23.3 | Percentage of Patients | |
| Overall Patient Incidence of BCAR | Alemtuzumab High-Risk Patients | 15.7 | Percentage of Patients | ||
| Overall Patient Incidence of BCAR | Conventional High-Risk Patients | 13.0 | Percentage of Patients | ||
| Overall Patient Incidence of BCAR | Alemtuzumab Low- Risk Patients | 9.8 | Percentage of Patients | ||
| Overall Patient Incidence of BCAR | Conventional Low-Risk Patients | 21.6 | Percentage of Patients | ||
| Efficacy Failure | Alemtuzumab High-Risk Patients | 22.9 | Percentage of Patients | ||
| Efficacy Failure | Conventional High-Risk Patients | 29.0 | Percentage of Patients |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alemtuzumab High-Risk Patients | 76 | |
| Overall Study | STARTED | Conventional High-Risk Patients | 70 | |
| Overall Study | STARTED | Alemtuzumab Low- Risk Patients | 175 | |
| Overall Study | STARTED | Conventional Low-Risk Patients | 180 | |
| Overall Study | Received Treatment | Alemtuzumab High-Risk Patients | 70 | |
| Overall Study | Received Treatment | Conventional High-Risk Patients | 69 | |
| Overall Study | Received Treatment | Alemtuzumab Low- Risk Patients | 164 | |
| Overall Study | Received Treatment | Conventional Low-Risk Patients | 171 | |
| Overall Study | COMPLETED | Alemtuzumab High-Risk Patients | 51 | |
| Overall Study | COMPLETED | Conventional High-Risk Patients | 48 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,080
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 | Alemtuzumab High-Risk Patients | 41 | 70 | |
| other | Anaemia | Blood and lymphatic system disorders | Conventional High-Risk Patients | 41 | 69 | |
| other | Anaemia | Blood and lymphatic system disorders | Alemtuzumab Low- Risk Patients | 90 | 164 | |
| other | Anaemia | Blood and lymphatic system disorders | Conventional Low-Risk Patients | 73 | 171 | |
| other | Leukopenia | Blood and lymphatic system disorders | Alemtuzumab High-Risk Patients | 38 | 70 | |
| other | Leukopenia | Blood and lymphatic system disorders | Conventional High-Risk Patients | 40 | 69 | |
| other | Leukopenia | Blood and lymphatic system disorders | Alemtuzumab Low- Risk Patients | 84 | 164 | |
| other | Leukopenia | Blood and lymphatic system disorders | Conventional Low-Risk Patients | 48 | 171 | |
| other | Neutropenia | Blood and lymphatic system disorders | Alemtuzumab High-Risk Patients | 8 | 70 | |
| other | Neutropenia | Blood and lymphatic system disorders | Conventional High-Risk Patients | 3 | 69 |
1 to 10 of 1,080Source ClinicalTrials.gov
See all 1,080 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alemtuzumab High-Risk Patients | ||
| Total, all-cause mortality | Conventional High-Risk Patients | ||
| Total, all-cause mortality | Alemtuzumab Low- Risk Patients | ||
| Total, all-cause mortality | Conventional Low-Risk Patients | ||
| Total, other adverse events | Alemtuzumab High-Risk Patients | 61 | 70 |
| Total, other adverse events | Conventional High-Risk Patients | 66 | 69 |
| Total, other adverse events | Alemtuzumab Low- Risk Patients | 151 | 164 |
| Total, other adverse events | Conventional Low-Risk Patients | 157 | 171 |
| Total, serious adverse events | Alemtuzumab High-Risk Patients | 33 | 70 |
| Total, serious adverse events | Conventional High-Risk Patients | 40 | 69 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21591943 | BACKGROUND |
Source PubMed
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/NCT00113269
GET https://conductscience.org/api/trials/v1/NCT00113269/results?page=2