Trial · NCT01114529
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
NCT01114529, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients. Trials, record NCT01114529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01114529
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
- NCT number
- NCT01114529
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 828 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Kidney Transplantation
- Interventions
- Everolimus, Prograf or Neoral
- First posted
- 2010-05-03
- Last updated
- 2017-05-30
- Other registries' IDs
- eudract:2009-015918-22
- Results first posted
- 2017-05-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimated Glomerular Filtration Rate (eGFR) | Month 12 | Assessment of renal function by comparing change from randomization to Month 12 in eGFR (MDRD4) between treatment arms (Full analysis set). Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR \[mL/min/1.73m˄2\] = 186.3\*(C˄-1.154)\*(A˄-0.203)\*G\*R. DEFINITIONS: C = serum concentration of creatinine \[mg/dL\]; A = age \[years\]; G = 0.742 when gender is female, otherwise G = 1; R = 1.21 when race is black, otherwise R = 1 |
| Secondary | Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | at 12 months and month 24 post-transplantation | Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)\*, (2) graft loss\*\*, or (3) death . \*A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. \*\*Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. |
| Secondary | Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24 | Randomization, Month 12 and Month 24 | Evolution of left ventricular mass and hypertrophy were evaluated by left ventricular mass index (LVMi) assessed by echocardiography. LVMi is derived using a standard formula from dimensional measurements on the echocardiogram. Analysis of covariance was applied with treatment, center (as a random effect), and donor type as factors and LVMi at Randomization as covariate. |
| Secondary | Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis) | at 24 months post-transplantation | (treated BPAR ≥ IB, graft loss or death)A comparison of the incidence rates for the individual components of the composite efficacy endpoint between treatment arms |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimated Glomerular Filtration Rate (eGFR) | Month 12 | Full Analysis set - observed eGFR values at month 12 (counted the patients with available values) | mL/min/1.73m^2 | MEAN |
| SECONDARY | Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | at 12 months and month 24 post-transplantation | Full Analysis Set | Number of incidence | NUMBER |
| SECONDARY | Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24 | Randomization, Month 12 and Month 24 | Full Analysis Set consists of only patients with triple LVMi values available at randomization, Month 12 and month 24 are included | g/m^2.7 | MEAN |
| SECONDARY | Comparison of Incidence Rates of Efficacy Endpoints Between Treatment Arms (Full Analysis Set - 24 Month Analysis) | at 24 months post-transplantation | Full Analysis Set | Number of incidence | NUMBER |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) | Everolimus | 64.1 | Standard Deviation 22.31 | mL/min/1.73m^2 | |
| Estimated Glomerular Filtration Rate (eGFR) | Standard CNI (Tac) | 61.5 | Standard Deviation 19.86 | mL/min/1.73m^2 | |
| Estimated Glomerular Filtration Rate (eGFR) | Standard CNI (CsA) | 58.4 | Standard Deviation 19.62 | mL/min/1.73m^2 | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Everolimus | Month 12 | 21 | Number of incidence | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Standard CNI (Tac) | Month 12 | 4 | Number of incidence | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Standard CNI (CsA) | Month 12 | 8 | Number of incidence | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Everolimus | Month 24 | 27 | Number of incidence | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Standard CNI (Tac) | Month 24 | 8 | Number of incidence | |
| Incidence of Composite Efficacy Endpoint for Each Arm at Month 12 and Month 24 | Standard CNI (CsA) | Month 24 | 8 | Number of incidence | |
| Change in Left Ventricular Mass Index (LVMi) From Randomization to Month 12 and Month 24 | Everolimus | Randomization | 50.30 | Standard Deviation 11.62 | g/m^2.7 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed Study Medication at Month 24 | STARTED | Everolimus | 353 | |
| Completed Study Medication at Month 24 | STARTED | Standard CNI (Tac) | 231 | |
| Completed Study Medication at Month 24 | STARTED | Standard CNI (CsA) | 125 | |
| Completed Study Medication at Month 24 | COMPLETED | Everolimus | 229 | |
| Completed Study Medication at Month 24 | COMPLETED | Standard CNI (Tac) | 190 | |
| Completed Study Medication at Month 24 | COMPLETED | Standard CNI (CsA) | 93 | |
| Completed Study Medication at Month 24 | NOT COMPLETED | Everolimus | 124 | |
| Completed Study Medication at Month 24 | NOT COMPLETED | Standard CNI (Tac) | 41 | |
| Completed Study Medication at Month 24 | NOT COMPLETED | Standard CNI (CsA) | 32 | |
| Completed Study Phase at Month 24 | STARTED | Everolimus | 353 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,104
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 | 41 | 346 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard CNI (Tac) | 21 | 238 | |
| other | Anaemia | Blood and lymphatic system disorders | Standard CNI (CsA) | 5 | 121 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus | 48 | 346 | |
| other | Leukopenia | Blood and lymphatic system disorders | Standard CNI (Tac) | 35 | 238 | |
| other | Leukopenia | Blood and lymphatic system disorders | Standard CNI (CsA) | 11 | 121 | |
| other | Diarrhoea | Gastrointestinal disorders | Everolimus | 79 | 346 | |
| other | Diarrhoea | Gastrointestinal disorders | Standard CNI (Tac) | 55 | 238 | |
| other | Diarrhoea | Gastrointestinal disorders | Standard CNI (CsA) | 13 | 121 | |
| other | Mouth ulceration | Gastrointestinal disorders | Everolimus | 24 | 346 |
1 to 10 of 1,104Source ClinicalTrials.gov
See all 1,104 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus | ||
| Total, all-cause mortality | Standard CNI (Tac) | ||
| Total, all-cause mortality | Standard CNI (CsA) | ||
| Total, other adverse events | Everolimus | 316 | 346 |
| Total, other adverse events | Standard CNI (Tac) | 216 | 238 |
| Total, other adverse events | Standard CNI (CsA) | 103 | 121 |
| Total, serious adverse events | Everolimus | 188 | 346 |
| Total, serious adverse events | Standard CNI (Tac) | 118 | 238 |
| Total, serious adverse events | Standard CNI (CsA) | 58 | 121 |
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 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/NCT01114529
GET https://conductscience.org/api/trials/v1/NCT01114529/results?page=2