Trial · NCT03468478
Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
NCT03468478, Phase 4, Completed, Hospital do Rim e Hipertensão; results first posted 2023-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation. Trials, record NCT03468478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03468478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
- NCT number
- NCT03468478
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,209 participants, actual
- Lead sponsor
- Hospital do Rim e Hipertensão
- Conditions
- Kidney Transplant Infection
- Interventions
- Sirolimus, Everolimus, Mycophenolic acid
- First posted
- 2018-03-16
- Last updated
- 2023-04-24
- Results first posted
- 2023-04-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Cytomegalovirus Infection or Disease | 12 months follow up | Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Cytomegalovirus Infection or Disease | 12 months follow up | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Cytomegalovirus Infection or Disease | Sirolimus +Tacrolimus | 9 | Participants | ||
| Incidence of Cytomegalovirus Infection or Disease | Everolimus +Tacrolimus | 7 | Participants | ||
| Incidence of Cytomegalovirus Infection or Disease | Mycophenolate +Tacrolimus | 39 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sirolimus +Tacrolimus | 403 | |
| Overall Study | STARTED | Everolimus +Tacrolimus | 403 | |
| Overall Study | STARTED | Mycophenolate +Tacrolimus | 403 | |
| Overall Study | COMPLETED | Sirolimus +Tacrolimus | 86 | |
| Overall Study | COMPLETED | Everolimus +Tacrolimus | 90 | |
| Overall Study | COMPLETED | Mycophenolate +Tacrolimus | 90 | |
| Overall Study | NOT COMPLETED | Sirolimus +Tacrolimus | 317 | |
| Overall Study | NOT COMPLETED | Everolimus +Tacrolimus | 313 | |
| Overall Study | NOT COMPLETED | Mycophenolate +Tacrolimus | 313 |
Source ClinicalTrials.gov
Adverse events36
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 |
|---|---|---|---|---|---|---|
| serious | CMV infection | Infections and infestations | Sirolimus +Tacrolimus | 5 | 86 | 5 |
| serious | CMV infection | Infections and infestations | Everolimus +Tacrolimus | 6 | 90 | 6 |
| serious | CMV infection | Infections and infestations | Mycophenolate +Tacrolimus | 24 | 90 | 25 |
| serious | Dehiscence of the aponeurosis | Skin and subcutaneous tissue disorders | Sirolimus +Tacrolimus | 1 | 86 | 1 |
| serious | Dehiscence of the aponeurosis | Skin and subcutaneous tissue disorders | Everolimus +Tacrolimus | 1 | 90 | 1 |
| serious | Dehiscence of the aponeurosis | Skin and subcutaneous tissue disorders | Mycophenolate +Tacrolimus | 2 | 90 | 2 |
| serious | Acute graft dysfunction | Renal and urinary disorders | Sirolimus +Tacrolimus | 1 | 86 | 1 |
| serious | Acute graft dysfunction | Renal and urinary disorders | Everolimus +Tacrolimus | 2 | 90 | 2 |
| serious | Acute graft dysfunction | Renal and urinary disorders | Mycophenolate +Tacrolimus | 0 | 90 | 0 |
| serious | Renal artery stenosis | Vascular disorders | Sirolimus +Tacrolimus | 1 | 86 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sirolimus +Tacrolimus | 2 | 86 |
| Total, all-cause mortality | Everolimus +Tacrolimus | 1 | 90 |
| Total, all-cause mortality | Mycophenolate +Tacrolimus | 3 | 90 |
| Total, other adverse events | Sirolimus +Tacrolimus | 0 | 86 |
| Total, other adverse events | Everolimus +Tacrolimus | 0 | 90 |
| Total, other adverse events | Mycophenolate +Tacrolimus | 0 | 90 |
| Total, serious adverse events | Sirolimus +Tacrolimus | 43 | 86 |
| Total, serious adverse events | Everolimus +Tacrolimus | 47 | 90 |
| Total, serious adverse events | Mycophenolate +Tacrolimus | 71 | 90 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37525373 | 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 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/NCT03468478
GET https://conductscience.org/api/trials/v1/NCT03468478/events?page=2