Trial · NCT00251004
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
NCT00251004, Phase 3, Completed, Novartis; results first posted 2011-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients. Trials, record NCT00251004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00251004
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
- NCT number
- NCT00251004
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 833 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Kidney Transplantation, Graft Rejection
- Interventions
- Everolimus, Mycophenolic Acid (MPA), Cyclosporine A (CsA), Basiliximab, Corticosteroids
- First posted
- 2005-11-09
- Last updated
- 2011-05-10
- Results first posted
- 2011-05-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | 12 months | The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. |
| Primary | Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints | 12 months | The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window. |
| Secondary | Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation | 12 months | Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant. A loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316. |
| Secondary | Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula | at 12 months | Modification of Diet in Renal Disease (MDRD) formula is: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where * C is the serum concentration of creatinine \[mg/dL\], * A is patient age at sample collection date \[years\], * G=0.742 when gender is female, otherwise G=1, * R=1.21 when race is black, otherwise R=1 |
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 | Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | 12 months | Intention-to-treat (ITT) population | Participants | NUMBER |
| SECONDARY | Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation | 12 months | Intention-to-treat (ITT) population. | Percentage of participants | NUMBER |
| PRIMARY | Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints | 12 months | Intention-to-treat population | Percentage of Participants | NUMBER |
| SECONDARY | Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula | at 12 months | Intention to treat (ITT) population. | mL/min/1.73m^2 | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Low-dose Everolimus Group | Composite Endpoint (n) | 75 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | High-dose Everolimus Group | Composite Endpoint (n) | 60 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Control Group | Composite Endpoint (n) | 70 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Low-dose Everolimus Group | --Death | 8 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | High-dose Everolimus Group | --Death | 9 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Control Group | --Death | 6 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Low-dose Everolimus Group | --Graft Loss | 13 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | High-dose Everolimus Group | --Graft Loss | 13 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Control Group | --Graft Loss | 9 | Participants | |
| Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis | Low-dose Everolimus Group | --Treated BPAR | 48 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-dose Everolimus Group | 277 | |
| Overall Study | STARTED | High-dose Everolimus Group | 279 | |
| Overall Study | STARTED | Control Group | 277 | |
| Overall Study | 12 Month Analysis | Low-dose Everolimus Group | 241 | |
| Overall Study | 12 Month Analysis | High-dose Everolimus Group | 249 | |
| Overall Study | 12 Month Analysis | Control Group | 253 | |
| Overall Study | 24 Month Analysis | Low-dose Everolimus Group | 232 | |
| Overall Study | 24 Month Analysis | High-dose Everolimus Group | 238 | |
| Overall Study | 24 Month Analysis | Control Group | 246 | |
| Overall Study | COMPLETED | Low-dose Everolimus Group | 232 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,566
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 | Low-dose Everolimus Group | 75 | 274 | |
| other | Anaemia | Blood and lymphatic system disorders | High-dose Everolimus Group | 86 | 278 | |
| other | Anaemia | Blood and lymphatic system disorders | Control Group | 67 | 273 | |
| other | Leukopenia | Blood and lymphatic system disorders | Low-dose Everolimus Group | 6 | 274 | |
| other | Leukopenia | Blood and lymphatic system disorders | High-dose Everolimus Group | 6 | 278 | |
| other | Leukopenia | Blood and lymphatic system disorders | Control Group | 30 | 273 | |
| other | Polycythaemia | Blood and lymphatic system disorders | Low-dose Everolimus Group | 14 | 274 | |
| other | Polycythaemia | Blood and lymphatic system disorders | High-dose Everolimus Group | 14 | 278 | |
| other | Polycythaemia | Blood and lymphatic system disorders | Control Group | 12 | 273 | |
| other | Tachycardia | Cardiac disorders | Low-dose Everolimus Group | 16 | 274 |
1 to 10 of 1,566Source ClinicalTrials.gov
See all 1,566 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low-dose Everolimus Group | ||
| Total, all-cause mortality | High-dose Everolimus Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Low-dose Everolimus Group | 268 | 274 |
| Total, other adverse events | High-dose Everolimus Group | 272 | 278 |
| Total, other adverse events | Control Group | 264 | 273 |
| Total, serious adverse events | Low-dose Everolimus Group | 176 | 274 |
| Total, serious adverse events | High-dose Everolimus Group | 193 | 278 |
| Total, serious adverse events | Control Group | 168 | 273 |
Source ClinicalTrials.gov
Papers3
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 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/NCT00251004
GET https://conductscience.org/api/trials/v1/NCT00251004/results?page=2