Trial · NCT00282256
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
NCT00282256, Phase 2, Completed, Astellas Pharma Inc; results first posted 2013-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients. Trials, record NCT00282256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00282256
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
- NCT number
- NCT00282256
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Astellas Pharma Inc
- Conditions
- Liver Transplantation
- Interventions
- tacrolimus modified release (MR), tacrolimus
- First posted
- 2006-01-26
- Last updated
- 2013-10-17
- Results first posted
- 2013-10-17
- 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 outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | The area under the concentration-time curve was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state using the linear trapezoidal rule. The AUC0-24 for tacrolimus was calculated as the sum of the AUC0-12 and AUC 12-24 for the morning and afternoon doses. |
| Primary | Minimum Observed Concentration of Tacrolimus (Cmin) | Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR). | The trough (minimum) concentration of tacrolimus determined from the tacrolimus whole blood concentration value at the 12 hour post-dose concentration based on the evening dose (i.e., the 8 am concentration) for tacrolimus and the 24-hour time point post-dose for tacrolimus MR, prior to receiving the next dose. |
| Primary | Patient Survival | From enrollment until the end of study (up to 54 months). | Patient survival was defined as any participant known to be alive at the end of the study. |
| Primary | Graft Survival | From enrollment until the end of study (up to 54 months). | Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was defined as graft failure (re-transplant) or participant death. |
| Secondary | Maximum Observed Concentration of Tacrolimus (Cmax) | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | The maximum concentration was calculated from whole blood tacrolimus concentrations for both the tacrolimus and tacrolimus MR at steady state, without interpolation. |
| Secondary | Time to Maximum Observed Concentration of Tacrolimus (Tmax) | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | Time to reach the first observed maximum concentration of tacrolimus was calculated from whole blood tacrolimus concentrations for both tacrolimus and tacrolimus MR at steady state, without interpolation. |
| Secondary | Percentage of Participants With Biopsy-confirmed Acute Rejection | From enrollment until the end of study (up to 54 months). | Biopsy-confirmed acute rejection (BCAR) is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the pathologist at the clinical site according to the 1997 Banff criteria for grading of acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I (Mild): Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II (Moderate): Rejection infiltrate, expanding to most or all of the triads; Grade III (Severe): Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte. necrosis |
| Secondary | Time to Event for Patient Non-survival | From enrollment until the end of study (up to 54 months). | For participants who died on study, the median number of days from first dose of study drug to death due to any cause. |
| Secondary | Time to Event for Graft Non-survival | From enrollment until the end of study (up to 54 months). | For participants with graft loss, the median number of days from the first dose of study drug to graft loss. Graft loss was defined as graft failure (re-transplant) or participant death. |
| Secondary | Time to First Biopsy-confirmed Acute Rejection | From enrollment until the end of study (up to 54 months). | For participants with a biopsy-confirmed acute rejection (BCAR), the median number of days from the first dose of study drug to the date of biopsy confirmation. BCAR is defined as an episode of acute liver allograft rejection that was confirmed by biopsy results and was Banff grade ≥ I. Biopsies were graded by the clinical site pathologist according to the 1997 Banff criteria for grading acute liver allograft rejection: Indeterminate: Portal inflammatory infiltrate that fails to meet the criteria for diagnosis of acute rejection; Grade I: Rejection infiltrate in a minority of the triads that is generally mild and confined within the portal spaces; Grade II: Rejection infiltrate, expanding to most or all of the triads; Grade III: Rejection infiltrate, expanding to most or all of the triads, with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | The pharmacokinetic evaluable set was defined as all patients who completed both pharmacokinetic profiles: one for tacrolimus, and one for tacrolimus MR. A complete pharmacokinetic profile was considered to be a profile that was adequate to determine AUC0-24, Cmax, and Cmin. | ng*hr/mL | MEAN |
| SECONDARY | Maximum Observed Concentration of Tacrolimus (Cmax) | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | Pharmacokinetic evaluable set. | ng/mL | MEAN |
| PRIMARY | Minimum Observed Concentration of Tacrolimus (Cmin) | Day 7 at 12 hours post-dose (tacrolimus) and Day 14 at 24 hours post-dose (tacrolimus MR). | Pharmacokinetic evaluable set. | ng/mL | MEAN |
| PRIMARY | Patient Survival | From enrollment until the end of study (up to 54 months). | The Modified Full Analysis Set included all patients who took at least 1 dose of tacrolimus MR formulation during the extended treatment period. | percentage of participants | NUMBER |
| PRIMARY | Graft Survival | From enrollment until the end of study (up to 54 months). | Modified full analysis set. | percentage of participants | NUMBER |
| SECONDARY | Time to Maximum Observed Concentration of Tacrolimus (Tmax) | For tacrolimus, Day 7 at 0 (pre-dose), 0.5, 1, 2, 3, 6, 8, 12 (pre-dose), 13, 14, 15, 18, 20, and 24 hours. For tacrolimus MR, Day 14 at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 18, 20, and 24 hours post-dose. | Pharmacokinetic evaluable set. | hours | MEDIAN |
| SECONDARY | Percentage of Participants With Biopsy-confirmed Acute Rejection | From enrollment until the end of study (up to 54 months). | Modified full analysis set. | percentage of participants | NUMBER |
| SECONDARY | Time to Event for Patient Non-survival | From enrollment until the end of study (up to 54 months). | Participants in the modified full analysis set who died on study. | days | MEDIAN |
| SECONDARY | Time to Event for Graft Non-survival | From enrollment until the end of study (up to 54 months). | Participants in the modified full analysis set with graft loss. | days | MEDIAN |
| SECONDARY | Time to First Biopsy-confirmed Acute Rejection | From enrollment until the end of study (up to 54 months). | Participants in the modified full analysis set with a biopsy-confirmed acute rejection. | days | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus | Tacrolimus MR | Day 7: Tacrolimus | 198.2 | Standard Deviation 99.2 | ng*hr/mL |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus | Tacrolimus MR | Day 14: Tacrolimus MR | 193.0 | Standard Deviation 78.0 | ng*hr/mL |
| Maximum Observed Concentration of Tacrolimus (Cmax) | Tacrolimus MR | Day 7: Tacrolimus | 20.7 | Standard Deviation 13.3 | ng/mL |
| Maximum Observed Concentration of Tacrolimus (Cmax) | Tacrolimus MR | Day 14: Tacrolimus MR | 15.2 | Standard Deviation 5.7 | ng/mL |
| Minimum Observed Concentration of Tacrolimus (Cmin) | Tacrolimus MR | Day 7: Tacrolimus | 5.9 | Standard Deviation 2.9 | ng/mL |
| Minimum Observed Concentration of Tacrolimus (Cmin) | Tacrolimus MR | Day 14: Tacrolimus MR | 5.3 | Standard Deviation 2.6 | ng/mL |
| Patient Survival | Tacrolimus MR | 94.44 | 95% Confidence Interval 83.86 to 100.00 | percentage of participants | |
| Graft Survival | Tacrolimus MR | 94.44 | 95% Confidence Interval 83.86 to 100.00 | percentage of participants | |
| Time to Maximum Observed Concentration of Tacrolimus (Tmax) | Tacrolimus MR | Day 7: Tacrolimus | 1.0 | Full Range 0.5 to 19.7 | hours |
| Time to Maximum Observed Concentration of Tacrolimus (Tmax) | Tacrolimus MR | Day 14: Tacrolimus MR | 2.0 | Full Range 0.9 to 6.0 | hours |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pharmacokinetic Treatment Period | STARTED | Tacrolimus MR | 19 | |
| Pharmacokinetic Treatment Period | Received Tacrolimus | Tacrolimus MR | 19 | |
| Pharmacokinetic Treatment Period | Received Tacrolimus MR | Tacrolimus MR | 18 | |
| Pharmacokinetic Treatment Period | COMPLETED | Tacrolimus MR | 18 | |
| Pharmacokinetic Treatment Period | NOT COMPLETED | Tacrolimus MR | 1 | |
| Extension Treatment Period | STARTED | Tacrolimus MR | 18 | |
| Extension Treatment Period | COMPLETED | Tacrolimus MR | 16 | |
| Extension Treatment Period | NOT COMPLETED | Tacrolimus MR | 2 |
Source ClinicalTrials.gov
Adverse events46
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 | Pneumonia | Infections and infestations | Tacrolimus MR | 2 | 18 | |
| other | Sinusitis | Infections and infestations | Tacrolimus MR | 2 | 18 | |
| other | Tinea capitis | Infections and infestations | Tacrolimus MR | 2 | 18 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Tacrolimus MR | 2 | 18 | |
| other | Bronchitis | Infections and infestations | Tacrolimus MR | 1 | 18 | |
| other | Cat scratch disease | Infections and infestations | Tacrolimus MR | 1 | 18 | |
| other | Ear infection | Infections and infestations | Tacrolimus MR | 1 | 18 | |
| other | Epstein-barr virus infection | Infections and infestations | Tacrolimus MR | 1 | 18 | |
| other | Escherichia urinary tract infection | Infections and infestations | Tacrolimus MR | 1 | 18 | |
| other | Gastroenteritis | Infections and infestations | Tacrolimus MR | 1 | 18 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tacrolimus MR | ||
| Total, other adverse events | Tacrolimus MR | 11 | 18 |
| Total, serious adverse events | Tacrolimus MR | 6 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17511684 | 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/NCT00282256
GET https://conductscience.org/api/trials/v1/NCT00282256/results?page=2