Trial · NCT03511560
Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
NCT03511560, Phase 4, Completed, Columbia University; results first posted 2024-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation. Trials, record NCT03511560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03511560
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation
- NCT number
- NCT03511560
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 50 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Renal Transplant Rejection, Kidney Transplant Failure and Rejection
- Interventions
- Tacrolimus Extended Release Oral Tablet, Tacrolimus
- First posted
- 2018-04-30
- Last updated
- 2024-07-17
- Results first posted
- 2024-07-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean C/D Ratio | Every Month for up to 1 year | Tacrolimus metabolism was determined for all dates of tacrolimus blood trough concentration collection after renal transplantation by dividing the tacrolimus blood trough concentration (C) by the corresponding total daily tacrolimus dose (D). C/D ratio (ng/mL\*1/mg) = blood tacrolimus trough level (ng/mL)/total daily tacrolimus dose (mg). |
| Secondary | Mean Serum Creatinine Level | 12 months | Serum creatinine levels were measured to assess kidney function following transplantation |
| Secondary | Patient Survival Rate | 12 months | Patient survival is any subject that is known to be alive at the study conclusion. |
| Secondary | Graft Survival Rate | 12 months | Graft survival is defined as any subject that does not fit the following definition of graft loss: subject death, re-transplantation, transplant nephrectomy, or return to dialysis for a period of ≥6 weeks by study end. |
| Secondary | Number of Rejection Episodes | 12 months | For study purposes, diagnoses of rejection require biopsy confirmation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean C/D Ratio | Every Month for up to 1 year | ng/mL*1/mg | MEAN | |
| SECONDARY | Mean Serum Creatinine Level | 12 months | mg/dL | MEAN | |
| SECONDARY | Patient Survival Rate | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Graft Survival Rate | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Rejection Episodes | 12 months | episodes | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean C/D Ratio | Tacrolimus, Immediate Release | Month 1 | 1.68 | Standard Deviation 1.09 | ng/mL*1/mg |
| Mean C/D Ratio | Envarsus XR | Month 1 | 1.47 | Standard Deviation .98 | ng/mL*1/mg |
| Mean C/D Ratio | Tacrolimus, Immediate Release | Month 2 | 1.86 | Standard Deviation .93 | ng/mL*1/mg |
| Mean C/D Ratio | Envarsus XR | Month 2 | 1.85 | Standard Deviation 1.07 | ng/mL*1/mg |
| Mean C/D Ratio | Tacrolimus, Immediate Release | Month 3 | 2.00 | Standard Deviation 1.17 | ng/mL*1/mg |
| Mean C/D Ratio | Envarsus XR | Month 3 | 1.95 | Standard Deviation 1.17 | ng/mL*1/mg |
| Mean C/D Ratio | Tacrolimus, Immediate Release | Month 6 | 1.92 | Standard Deviation 1.07 | ng/mL*1/mg |
| Mean C/D Ratio | Envarsus XR | Month 6 | 2.86 | Standard Deviation 2.13 | ng/mL*1/mg |
| Mean C/D Ratio | Tacrolimus, Immediate Release | Month 9 | 2.05 | Standard Deviation 0.91 | ng/mL*1/mg |
| Mean C/D Ratio | Envarsus XR | Month 9 | 2.77 | Standard Deviation 2.33 | ng/mL*1/mg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tacrolimus, Immediate Release | 25 | |
| Overall Study | STARTED | Envarsus XR | 25 | |
| Overall Study | COMPLETED | Tacrolimus, Immediate Release | 24 | |
| Overall Study | COMPLETED | Envarsus XR | 21 | |
| Overall Study | NOT COMPLETED | Tacrolimus, Immediate Release | 1 | |
| Overall Study | NOT COMPLETED | Envarsus XR | 4 |
Source ClinicalTrials.gov
Adverse events8
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 | BK Viremia | Infections and infestations | Tacrolimus, Immediate Release | 6 | 24 | 6 |
| other | BK Viremia | Infections and infestations | Envarsus XR | 4 | 21 | 4 |
| other | Cytomegalovirus | Infections and infestations | Tacrolimus, Immediate Release | 1 | 24 | 1 |
| other | Cytomegalovirus | Infections and infestations | Envarsus XR | 1 | 21 | 1 |
| other | Epstein-Barr Virus | Infections and infestations | Tacrolimus, Immediate Release | 0 | 24 | 0 |
| other | Epstein-Barr Virus | Infections and infestations | Envarsus XR | 1 | 21 | 1 |
| other | COVID-19 infection | Infections and infestations | Tacrolimus, Immediate Release | 1 | 24 | 1 |
| other | COVID-19 infection | Infections and infestations | Envarsus XR | 0 | 21 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tacrolimus, Immediate Release | 0 | 24 |
| Total, all-cause mortality | Envarsus XR | 0 | 21 |
| Total, other adverse events | Tacrolimus, Immediate Release | 8 | 24 |
| Total, other adverse events | Envarsus XR | 6 | 21 |
| Total, serious adverse events | Tacrolimus, Immediate Release | 0 | 24 |
| Total, serious adverse events | Envarsus XR | 0 | 21 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tacrolimus, Immediate Release vs Envarsus XR: Patient Survival Rate | Trial comparisons |
| Tacrolimus, Immediate Release vs Envarsus XR: deaths from any cause | Trial comparisons |
| Tacrolimus, Immediate Release vs Envarsus XR: Graft Survival Rate | Trial comparisons |
| Tacrolimus, Immediate Release vs Envarsus XR: 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/NCT03511560
GET https://conductscience.org/api/trials/v1/NCT03511560/results?page=2