Trial · NCT03289650
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
NCT03289650, Phase 3, Completed, Lorenzo Gallon; results first posted 2023-04-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Extended Release Tacrolimus vs. Twice-Daily Tacrolimus. Trials, record NCT03289650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03289650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
- NCT number
- NCT03289650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 29 participants, actual
- Lead sponsor
- Lorenzo Gallon
- Conditions
- End Stage Renal Disease, Rejection of Renal Transplant
- Interventions
- Tacrolimus, Tacrolimus Extended Release Oral Tablet [Envarsus]
- First posted
- 2017-09-21
- Last updated
- 2023-04-10
- Results first posted
- 2023-04-10
- Limitations and caveats
- The study ran out of funding and as a result the outcome (Change in Subpopulations of T Cells) has not been analyzed. The PI will look for additional funding to complete the analysis
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant | 2 weeks post transplant through 12 months post transplant | change in the mean eGFR from the baseline (2 weeks post transplant), 3 months (post transplant) , and 12 months (post transplant). |
| Secondary | Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant | Measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant | Blood, urine and kidney tissue analysis via serial flow cytometric immunophenotyping (includes regulatory T and B cell populations as well as immune functions). |
| Secondary | Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Measured at 3 months post transplant, 12 months post transplant | Acute rejection of kidney transplant is determined via biopsy. |
| Secondary | Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Measured at 3 months post transplant, 12 months post transplant | Graft loss is determined via biopsy. |
| Secondary | Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant | Through 12 months post transplant | Subject survival status is continually monitored via routine follow-up visits. |
| Secondary | Number of Participants With Change in Allograft Immunohistopathology Profile | Measured at 3 months post transplant, 12 months post transplant | Tissue analysis via immunohistopathological staining and microscopic examination Moderate acute tubular necrosis =\> presence of focal coagulative necrosis or infarction on histopathologic examination Arteriolar hyalinosis grade 2 means: Replacement of degenerated smooth muscle cells by hyaline deposits in more than 1 arteriole, without circumferential involvement Global glomerulosclerosis \>grade 2, means glomerulosclerosis affecting more than 50% of glomeruli in the biopsy sample IFTA : Interstitial fibrosis and tubular atrophy: Inflammation in 26% to 50% of scarred cortical parenchyma |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant | 2 weeks post transplant through 12 months post transplant | mL/min/1.73m^2 | MEAN | |
| SECONDARY | Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant | Measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant | Secondary outcome data will not be reported because support to collect secondary data was not present | ||
| SECONDARY | Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Measured at 3 months post transplant, 12 months post transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Measured at 3 months post transplant, 12 months post transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Deceased at at 3 Months and 12 Months Post-Transplant | Through 12 months post transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Change in Allograft Immunohistopathology Profile | Measured at 3 months post transplant, 12 months post transplant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | 2.03 | Standard Error 1.71 | mL/min/1.73m^2 | |
| Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | -2.19 | Standard Error 1.77 | mL/min/1.73m^2 | |
| Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Acute rejection at 3 months | 0 | Participants | |
| Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus® XR (LCP-Tacro/Envarsus XR) | Acute rejection at 3 months | 1 | Participants | |
| Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Acute rejection at 12 months | 0 | Participants | |
| Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus® XR (LCP-Tacro/Envarsus XR) | Acute rejection at 12 months | 2 | Participants | |
| Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Graft Loss at 3 months | 0 | Participants | |
| Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | Graft Loss at 3 months | 0 | Participants | |
| Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | Graft loss at 12 months | 0 | Participants | |
| Number of Participants With Graft Loss at 3 Months and 12 Months Post-Transplant | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | Graft loss at 12 months | 0 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | 14 | |
| Overall Study | STARTED | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | 15 | |
| Overall Study | COMPLETED | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | 14 | |
| Overall Study | COMPLETED | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | 15 | |
| Overall Study | NOT COMPLETED | Group 1: Control Arm: Standard of Care (SOC) Tacrolimus | 0 | |
| Overall Study | NOT COMPLETED | Group 2: Interventional Arm: Study Related Drug: LCP-Tacrolimus/Envarsus XR (LCP-Tacro/Envarsus XR) | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Infections | Immune system disorders | Standard of Care Tacrolimus Twice-daily | 1 | 14 | 1 |
| other | Infections | Immune system disorders | Extended-release Tacrolimus Once-daily | 1 | 15 | 1 |
| other | Malignancy | Immune system disorders | Standard of Care Tacrolimus Twice-daily | 0 | 14 | 0 |
| other | Malignancy | Immune system disorders | Extended-release Tacrolimus Once-daily | 0 | 15 | 0 |
| other | Leukopenia | Immune system disorders | Standard of Care Tacrolimus Twice-daily | 4 | 14 | 4 |
| other | Leukopenia | Immune system disorders | Extended-release Tacrolimus Once-daily | 4 | 15 | 4 |
| other | BK Viremia | Renal and urinary disorders | Standard of Care Tacrolimus Twice-daily | 2 | 14 | 2 |
| other | BK Viremia | Renal and urinary disorders | Extended-release Tacrolimus Once-daily | 0 | 15 | 0 |
| serious | Hospitalizations | Renal and urinary disorders | Standard of Care Tacrolimus Twice-daily | 0 | 14 | 0 |
| serious | Hospitalizations | Renal and urinary disorders | Extended-release Tacrolimus Once-daily | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care Tacrolimus Twice-daily | 0 | 14 |
| Total, all-cause mortality | Extended-release Tacrolimus Once-daily | 0 | 15 |
| Total, other adverse events | Standard of Care Tacrolimus Twice-daily | 7 | 14 |
| Total, other adverse events | Extended-release Tacrolimus Once-daily | 5 | 15 |
| Total, serious adverse events | Standard of Care Tacrolimus Twice-daily | 0 | 14 |
| Total, serious adverse events | Extended-release Tacrolimus Once-daily | 1 | 15 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Extended-release Tacrolimus Once-daily vs Standard of Care Tacrolimus Twice-daily: deaths from any cause | Trial comparisons |
| Extended-release Tacrolimus Once-daily vs Standard of Care Tacrolimus Twice-daily: 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/NCT03289650
GET https://conductscience.org/api/trials/v1/NCT03289650/results?page=2