Trial · NCT01950819
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
NCT01950819, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM). Trials, record NCT01950819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950819
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
- NCT number
- NCT01950819
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,037 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation
- Interventions
- Induction therapy, Corticosteroids, EVR+rCNI, MPA+sCNI
- First posted
- 2013-09-26
- Last updated
- 2019-01-30
- Other registries' IDs
- eudract:2013-000322-66
- Results first posted
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | Month 12 is Primary, Month 24 secondary | Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2. |
| Secondary | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | Month 12 and 24 | Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death |
| Secondary | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR \< 50 mL/min/1.73m2 |
| Secondary | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | Month 12 and 24 | Incidence of failure on the composite endpoint of graft loss or death. |
| Secondary | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | Month 12 and 24 | Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) |
| Secondary | Incidence of eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of eGFR \< 50 mL/min/1.73m2 |
| Secondary | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | Baseline (week 4), Month 12 and 24 | Renal allograft function : mean estimated glomerular filtration rate, eGFR |
| Secondary | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | Month 12 and 24 | Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. |
| Secondary | Renal Function Assessed by Creatinine Lab Values | Month 12 and 24 | Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. |
| Secondary | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | Month 12 and 24 | Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | Month 12 is Primary, Month 24 secondary | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | Baseline (week 4), Month 12 and 24 | full analysis set | mL/min/1.73m2 | MEAN |
| SECONDARY | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | Month 12 and 24 | full analysis set | mL / min / 1.73m2 / day | MEAN |
| SECONDARY | Renal Function Assessed by Creatinine Lab Values | Month 12 and 24 | full analysis set with measure | micromol/L | MEAN |
| SECONDARY | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | Month 12 and 24 | full analysis set with measure | mL/min/1.73m2 | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | EVR+rCNI | month 12 | 489 | Participants | |
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | MPA+sCNI | month 12 | 456 | Participants | |
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | EVR+rCNI | month 24 | 489 | Participants | |
| Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | MPA+sCNI | month 24 | 443 | Participants | |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | EVR+rCNI | month 12 | 146 | Participants | |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | MPA+sCNI | month 12 | 131 | Participants | |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | EVR+rCNI | month 24 | 169 | Participants | |
| Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | MPA+sCNI | month 24 | 147 | Participants | |
| Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | EVR+rCNI | month 12 | 497 | Participants | |
| Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | MPA+sCNI | month 12 | 466 | Participants |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EVR+rCNI | 1,022 | |
| Overall Study | STARTED | MPA+sCNI | 1,015 | |
| Overall Study | COMPLETED | EVR+rCNI | 893 | |
| Overall Study | COMPLETED | MPA+sCNI | 881 | |
| Overall Study | NOT COMPLETED | EVR+rCNI | 129 | |
| Overall Study | NOT COMPLETED | MPA+sCNI | 134 |
Source ClinicalTrials.gov
Adverse events1,650
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 | Anaemia | Blood and lymphatic system disorders | Everolimus Plus@Reduced CNI | 227 | 1,014 | |
| other | Anaemia | Blood and lymphatic system disorders | MPA Plus Standard@CNI | 238 | 1,012 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Everolimus Plus@Reduced CNI | 24 | 1,014 | |
| other | Leukocytosis | Blood and lymphatic system disorders | MPA Plus Standard@CNI | 58 | 1,012 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus Plus@Reduced CNI | 94 | 1,014 | |
| other | Leukopenia | Blood and lymphatic system disorders | MPA Plus Standard@CNI | 194 | 1,012 | |
| other | Polycythaemia | Blood and lymphatic system disorders | Everolimus Plus@Reduced CNI | 52 | 1,014 | |
| other | Polycythaemia | Blood and lymphatic system disorders | MPA Plus Standard@CNI | 42 | 1,012 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus Plus@Reduced CNI | 74 | 1,014 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MPA Plus Standard@CNI | 41 | 1,012 |
1 to 10 of 1,650Source ClinicalTrials.gov
See all 1,650 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus Plus@Reduced CNI | 20 | 1,014 |
| Total, all-cause mortality | MPA Plus Standard@CNI | 29 | 1,012 |
| Total, other adverse events | Everolimus Plus@Reduced CNI | 951 | 1,014 |
| Total, other adverse events | MPA Plus Standard@CNI | 942 | 1,012 |
| Total, serious adverse events | Everolimus Plus@Reduced CNI | 593 | 1,014 |
| Total, serious adverse events | MPA Plus Standard@CNI | 613 | 1,012 |
Source ClinicalTrials.gov
Papers5
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EVR+rCNI vs MPA+sCNI: Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | Trial comparisons |
| EVR+rCNI vs MPA+sCNI: Incidence of Major Cardiovascular Events. | Trial comparisons |
| Everolimus Plus@Reduced CNI vs MPA Plus Standard@CNI: deaths from any cause | Trial comparisons |
| EVR+rCNI vs MPA+sCNI: Incidence of Malignancies. | Trial comparisons |
| Everolimus Plus@Reduced CNI vs MPA Plus Standard@CNI: 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/NCT01950819
GET https://conductscience.org/api/trials/v1/NCT01950819/registered?page=2