Trial · NCT01962922
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
NCT01962922, Phase 3, Completed, Asahi Kasei Therapeutics, Inc.; results first posted 2016-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily. Trials, record NCT01962922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01962922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.
- NCT number
- NCT01962922
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, Inc.
- Conditions
- Renal Failure
- Interventions
- LCP-Tacro, Tacrolimus -IR
- First posted
- 2013-10-14
- Last updated
- 2018-06-06
- Results first posted
- 2016-08-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 7 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 7 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 7 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 14 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 14 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 14 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours |
| Primary | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 21 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 21 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
| Primary | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 21 | Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 7 | For this outcome measure the PK population N=46 was used. | ng*hr/mL | MEAN |
| PRIMARY | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 7 | For this outcome measuure the Protocol PK population of N = 46 was used. | ng/mL | MEAN |
| PRIMARY | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 7 | For this outcome measure the Protocol PK population N= 46 was used. | ng/mL | MEAN |
| PRIMARY | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 14 | For this outcome measure the PK population N=46 was used | ng*hr/mL | MEAN |
| PRIMARY | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 14 | For this outcome measuure the Protocol PK population of N = 46 was used. | ng/mL | MEAN |
| PRIMARY | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 14 | For this outcome measuure the Protocol PK population N= 46 was used. | ng/mL | MEAN |
| PRIMARY | Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Day 21 | For this outcome measure the PK population N=46 was used. | ng*hr/mL | MEAN |
| PRIMARY | Evaluation of C(Max) for Envarsus XR and IR-Tac | Day 21 | For this outcome measuure the Protocol PK population of N = 46 was used. | ng/mL | MEAN |
| PRIMARY | Evaluation of C(Min) for Envarsus XR and IR-Tac | Day 21 | For this outcome measure the Protocol PK population N= 46 was used. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Envarsus XR | 251.9 | Standard Deviation 77.78 | ng*hr/mL | |
| Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Tacrolimus - IR | 247.9 | Standard Deviation 102.33 | ng*hr/mL | |
| Evaluation of C(Max) for Envarsus XR and IR-Tac | Envarsus XR | 16.53 | Standard Deviation 5.464 | ng/mL | |
| Evaluation of C(Max) for Envarsus XR and IR-Tac | Tacrolimus - IR | 26.84 | Standard Deviation 13.296 | ng/mL | |
| Evaluation of C(Min) for Envarsus XR and IR-Tac | Envarsus XR | 7.51 | Standard Deviation 2.487 | ng/mL | |
| Evaluation of C(Min) for Envarsus XR and IR-Tac | Tacrolimus - IR | 7.06 | Standard Deviation 2.843 | ng/mL | |
| Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Envarsus XR | 293.3 | Standard Deviation 124.40 | ng*hr/mL | |
| Evaluation of AUC(0-24) for Envarsus XR and IR-Tac | Tacrolimus - IR | 225.7 | Standard Deviation 56.27 | ng*hr/mL | |
| Evaluation of C(Max) for Envarsus XR and IR-Tac | Envarsus XR | 20.83 | Standard Deviation 9.265 | ng/mL | |
| Evaluation of C(Max) for Envarsus XR and IR-Tac | Tacrolimus - IR | 26.31 | Standard Deviation 13.296 | ng/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PK Portion Day 7 | STARTED | Sequence 1 | 27 | |
| PK Portion Day 7 | STARTED | Sequence 2 | 23 | |
| PK Portion Day 7 | COMPLETED | Sequence 1 | 23 | |
| PK Portion Day 7 | COMPLETED | Sequence 2 | 23 | |
| PK Portion Day 7 | NOT COMPLETED | Sequence 1 | 4 | |
| PK Portion Day 7 | NOT COMPLETED | Sequence 2 | 0 | |
| PK Portion Day 14 | STARTED | Sequence 1 | 23 | |
| PK Portion Day 14 | STARTED | Sequence 2 | 23 | |
| PK Portion Day 14 | COMPLETED | Sequence 1 | 23 | |
| PK Portion Day 14 | COMPLETED | Sequence 2 | 23 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events38
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 | Constipation | Gastrointestinal disorders | Envarsus XR | 0 | 50 | 0 |
| other | Constipation | Gastrointestinal disorders | Tacrolimus - IR | 3 | 50 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Envarsus XR | 3 | 50 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Tacrolimus - IR | 3 | 50 | 3 |
| other | Nausea | Gastrointestinal disorders | Envarsus XR | 3 | 50 | 3 |
| other | Nausea | Gastrointestinal disorders | Tacrolimus - IR | 3 | 50 | 3 |
| other | Nasopharyngitis | Infections and infestations | Envarsus XR | 3 | 50 | 3 |
| other | Nasopharyngitis | Infections and infestations | Tacrolimus - IR | 5 | 50 | 5 |
| other | Blood creatinine increased | Investigations | Envarsus XR | 7 | 50 | 8 |
| other | Blood creatinine increased | Investigations | Tacrolimus - IR | 4 | 50 | 4 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Envarsus XR | ||
| Total, all-cause mortality | Tacrolimus - IR | ||
| Total, other adverse events | Envarsus XR | 23 | 50 |
| Total, other adverse events | Tacrolimus - IR | 22 | 50 |
| Total, serious adverse events | Envarsus XR | 3 | 50 |
| Total, serious adverse events | Tacrolimus - IR | 4 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29162334 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Envarsus XR vs Tacrolimus - IR: serious adverse events |
Source 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/NCT01962922
GET https://conductscience.org/api/trials/v1/NCT01962922/flow?page=2