Trial · NCT01936519
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
NCT01936519, Not applicable, Completed, Milton S. Hershey Medical Center; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation. Trials, record NCT01936519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01936519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
- NCT number
- NCT01936519
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 24 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Immunosuppression, Renal Failure
- Interventions
- Arm A: Everolimus, Calcineurin Inhibitor
- First posted
- 2013-09-06
- Last updated
- 2021-01-29
- Results first posted
- 2021-01-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 6 months, 1 year, and 2 years | Renal Function was assessed by 24 hr urine collection creatinine clearance measured (mL/min). 24 Hr urine collection was assessed at baseline, 6 months, 1 year, and 2 years post transplant. |
| Primary | Renal Function as Measured by Serum Creatinine Level | 6 months, 1 year, and 2 years | Serum creatinine levels were assessed at 6 months, 1 year, and 2 years post transplant |
| Primary | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | 6 months, 1 year, and 2 years | The Cockcroft-Gault formula for estimating creatinine clearance was determined at 6 months, 1 year, and 2 years post transplant |
| Primary | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | 6 months, 1 year, and 2 years | Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR) was assessed at 6 months, 1 year, and 2 years post transplant. |
| Primary | Renal Function as Measured by Iothalamate Clearance | 6 months, 1 year, and 2 years | Iothalamate Clearance was assessed at 6 months, 1 year, and 2 years post transplant. |
| Other | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | 2 years | A blood sample was obtained from recipients and donors to measure gene polymorphism effects on metabolism of calcineurin inhibitor and everolimus. The polymorphisms are represented as the number of SNP occurrences for the CYP3A5, ABCB1 (MDR1) gene, and CYP4A4\*22 genes. |
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 | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 6 months, 1 year, and 2 years | mL/min | MEAN | |
| PRIMARY | Renal Function as Measured by Serum Creatinine Level | 6 months, 1 year, and 2 years | mg/dL | MEAN | |
| PRIMARY | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | 6 months, 1 year, and 2 years | mL/min/1.73m2 | MEAN | |
| PRIMARY | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | 6 months, 1 year, and 2 years | mL/min/1.73 m2 | MEAN | |
| PRIMARY | Renal Function as Measured by Iothalamate Clearance | 6 months, 1 year, and 2 years | mL/min/1.73m2 | MEAN | |
| OTHER_PRE_SPECIFIED | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | 2 years | SNP source: rs776746 = CYP3A5 gene; rs1045642, rs1128503 and rs2032582 = ABCB1 (MDR1) gene, and rs35599367=Cyp4A4\*22 gene. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Calcineurin Inhibitor With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 6 months | 68.09 | Standard Deviation 30.08 | mL/min |
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Everolimus With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 6 months | 70.75 | Standard Deviation 29.03 | mL/min |
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Calcineurin Inhibitor With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 1 year | 68.09 | Standard Deviation 28.91 | mL/min |
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Everolimus With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 1 year | 86.8 | Standard Deviation 29.34 | mL/min |
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Calcineurin Inhibitor With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 2 years | 61.54 | Standard Deviation 27.5 | mL/min |
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | Everolimus With Mycophenolic Acid | 24hr Urine Creatinine Clearance at 2 years | 90.63 | Standard Deviation 30.05 | mL/min |
| Renal Function as Measured by Serum Creatinine Level | Calcineurin Inhibitor and Mycophenolic Acid | Serum Creatinine at 6 months | 1.29 | Standard Deviation 0.43 | mg/dL |
| Renal Function as Measured by Serum Creatinine Level | Everolimus and Mycophenolic Acid | Serum Creatinine at 6 months | 1.02 | Standard Deviation 0.24 | mg/dL |
| Renal Function as Measured by Serum Creatinine Level | Calcineurin Inhibitor and Mycophenolic Acid | Serum Creatinine at 1 year | 1.29 | Standard Deviation 0.38 | mg/dL |
| Renal Function as Measured by Serum Creatinine Level | Everolimus and Mycophenolic Acid | Serum Creatinine at 1 year | 0.95 | Standard Deviation 0.25 | mg/dL |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Calcineurin Inhibitor and Mycophenolic Acid | 12 | |
| Overall Study | STARTED | Everolimus and Mycophenolic Acid | 12 | |
| Overall Study | COMPLETED | Calcineurin Inhibitor and Mycophenolic Acid | 11 | |
| Overall Study | COMPLETED | Everolimus and Mycophenolic Acid | 8 | |
| Overall Study | NOT COMPLETED | Calcineurin Inhibitor and Mycophenolic Acid | 1 | |
| Overall Study | NOT COMPLETED | Everolimus and Mycophenolic Acid | 4 |
Source ClinicalTrials.gov
Adverse events76
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 | Leukopenia | Immune system disorders | Calcineurin Inhibitor and Mycophenolic Acid | 7 | 12 | 7 |
| other | Leukopenia | Immune system disorders | Everolimus and Mycophenolic Acid | 9 | 12 | 9 |
| other | Hyperlipidemia | Metabolism and nutrition disorders | Calcineurin Inhibitor and Mycophenolic Acid | 7 | 12 | 7 |
| other | Hyperlipidemia | Metabolism and nutrition disorders | Everolimus and Mycophenolic Acid | 9 | 12 | 9 |
| other | Cellular Rejection | Immune system disorders | Calcineurin Inhibitor and Mycophenolic Acid | 1 | 12 | 1 |
| other | Cellular Rejection | Immune system disorders | Everolimus and Mycophenolic Acid | 3 | 12 | 3 |
| other | antibody mediated rejection | Immune system disorders | Calcineurin Inhibitor and Mycophenolic Acid | 1 | 12 | 1 |
| other | antibody mediated rejection | Immune system disorders | Everolimus and Mycophenolic Acid | 2 | 12 | 2 |
| other | Cytomegalovirus Infection | Infections and infestations | Calcineurin Inhibitor and Mycophenolic Acid | 6 | 12 | 6 |
| other | Cytomegalovirus Infection | Infections and infestations | Everolimus and Mycophenolic Acid | 2 | 12 | 2 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Calcineurin Inhibitor and Mycophenolic Acid | 0 | 12 |
| Total, all-cause mortality | Everolimus and Mycophenolic Acid | 0 | 12 |
| Total, other adverse events | Calcineurin Inhibitor and Mycophenolic Acid | 12 | 12 |
| Total, other adverse events | Everolimus and Mycophenolic Acid | 12 | 12 |
| Total, serious adverse events | Calcineurin Inhibitor and Mycophenolic Acid | 0 | 12 |
| Total, serious adverse events | Everolimus and Mycophenolic Acid | 1 | 12 |
Source ClinicalTrials.gov
Papers29
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Calcineurin Inhibitor and Mycophenolic Acid vs Everolimus and Mycophenolic Acid: deaths from any cause | Trial comparisons |
| Calcineurin Inhibitor and Mycophenolic Acid vs Everolimus and Mycophenolic Acid: 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/NCT01936519
GET https://conductscience.org/api/trials/v1/NCT01936519/results?page=2