Trial · NCT00634920
Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
NCT00634920, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2014-08-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients. Trials, record NCT00634920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00634920
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
- NCT number
- NCT00634920
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 204 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Renal Function
- Interventions
- everolimus, cyclosporine A, Enteric Coated Mycophenolate Sodium (EC-MPS), corticosteroids, Basiliximab
- First posted
- 2008-03-13
- Last updated
- 2014-08-13
- Other registries' IDs
- eudract:2007-000771-42
- Results first posted
- 2014-08-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Measured Glomerular Filtration Rate | Month 12 | To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. |
| Secondary | Measured Glomerular Filtration Rate | Month 36 | Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice. |
| Secondary | Calculated Glomerular Filtration Rate | Months 12, 36 | The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points. |
| Secondary | Progression of Measured Glomerular Filtration Rate | Week 7, Week 52, Month 36 | Change in renal progression measured by mean mGFR from week 7 to Month 36 |
| Secondary | Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy) | Month 12, Month 36 | Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space) |
| Secondary | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | Months 12, 24, 36 | A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising \> 25% of the lumenal area. |
| Secondary | Percentage of Participants With Graft Loss or Death | Months 12, 24, 36 | The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event). |
| Secondary | Time to Treatment Failure | Months 12, 24, 36 | Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure. |
| Secondary | Percentage of Participants With Treatment Failures | Months 12, 24, 36 | Treatment failure was defined as graft loss or death. |
| Secondary | Time to First Malignancy | Months 12, 24, 36 | This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measured Glomerular Filtration Rate | Month 12 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | mL/min/1.73m^2 | MEAN |
| SECONDARY | Measured Glomerular Filtration Rate | Month 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Calculated Glomerular Filtration Rate | Months 12, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | mL/min/1.73m^2 | MEAN |
| SECONDARY | Progression of Measured Glomerular Filtration Rate | Week 7, Week 52, Month 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | mL/min/1.73m^2 | MEAN |
| SECONDARY | Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy) | Month 12, Month 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) | Months 12, 24, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Graft Loss or Death | Months 12, 24, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure | Months 12, 24, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Days | MEAN |
| SECONDARY | Percentage of Participants With Treatment Failures | Months 12, 24, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Percentage of participants | NUMBER |
| SECONDARY | Time to First Malignancy | Months 12, 24, 36 | The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). | Months | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Measured Glomerular Filtration Rate | Everolimus (CNI-free) | 51.5 | Standard Deviation 14.4 | mL/min/1.73m^2 | |
| Measured Glomerular Filtration Rate | Control (CsA) | 47.8 | Standard Deviation 15.4 | mL/min/1.73m^2 | |
| Measured Glomerular Filtration Rate | Everolimus (CNI-free) | 48.2 | Standard Deviation 14.7 | mL/min/1.73m^2 | |
| Measured Glomerular Filtration Rate | Control (CsA) | 46.1 | Standard Deviation 17.0 | mL/min/1.73m^2 | |
| Calculated Glomerular Filtration Rate | Everolimus (CNI-free) | MDRD M12 | 65.0 | Standard Deviation 19.9 | mL/min/1.73m^2 |
| Calculated Glomerular Filtration Rate | Control (CsA) | MDRD M12 | 60.1 | Standard Deviation 19.7 | mL/min/1.73m^2 |
| Calculated Glomerular Filtration Rate | Everolimus (CNI-free) | MDRD M36 | 59.4 | Standard Deviation 20.1 | mL/min/1.73m^2 |
| Calculated Glomerular Filtration Rate | Control (CsA) | MDRD M36 | 57.4 | Standard Deviation 20.2 | mL/min/1.73m^2 |
| Calculated Glomerular Filtration Rate | Everolimus (CNI-free) | Cockcroft-Gault M12 | 45.4 | Standard Deviation 14.6 | mL/min/1.73m^2 |
| Calculated Glomerular Filtration Rate | Control (CsA) | Cockcroft-Gault M12 | 45.6 | Standard Deviation 15.4 | mL/min/1.73m^2 |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 - Pre-Randomization | STARTED | Everolimus (CNI-free) | 0 | |
| Period 1 - Pre-Randomization | STARTED | Control (CsA) | 0 | |
| Period 1 - Pre-Randomization | STARTED | Pre-Randomized Patients | 341 | |
| Period 1 - Pre-Randomization | COMPLETED | Everolimus (CNI-free) | 0 | |
| Period 1 - Pre-Randomization | COMPLETED | Control (CsA) | 0 | |
| Period 1 - Pre-Randomization | COMPLETED | Pre-Randomized Patients | 204 | |
| Period 1 - Pre-Randomization | NOT COMPLETED | Everolimus (CNI-free) | 0 | |
| Period 1 - Pre-Randomization | NOT COMPLETED | Control (CsA) | 0 | |
| Period 1 - Pre-Randomization | NOT COMPLETED | Pre-Randomized Patients | 137 | |
| Period 2 - Post-Randomization | STARTED | Everolimus (CNI-free) | 104 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events388
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 | Control (CsA) | 12 | 100 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus (CNI-free) | 24 | 102 | |
| other | Leukopenia | Blood and lymphatic system disorders | Control (CsA) | 10 | 100 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus (CNI-free) | 15 | 102 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Control (CsA) | 0 | 100 | |
| other | Aphthous stomatitis | Gastrointestinal disorders | Everolimus (CNI-free) | 14 | 102 | |
| other | Diarrhoea | Gastrointestinal disorders | Control (CsA) | 15 | 100 | |
| other | Diarrhoea | Gastrointestinal disorders | Everolimus (CNI-free) | 12 | 102 | |
| other | Gingival hyperplasia | Gastrointestinal disorders | Control (CsA) | 10 | 100 | |
| other | Gingival hyperplasia | Gastrointestinal disorders | Everolimus (CNI-free) | 0 | 102 |
1 to 10 of 388Source ClinicalTrials.gov
See all 388 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control (CsA) | ||
| Total, all-cause mortality | Everolimus (CNI-free) | ||
| Total, other adverse events | Control (CsA) | 88 | 100 |
| Total, other adverse events | Everolimus (CNI-free) | 93 | 102 |
| Total, serious adverse events | Control (CsA) | 65 | 100 |
| Total, serious adverse events | Everolimus (CNI-free) | 72 | 102 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Everolimus (CNI-free) vs Control (CsA): serious adverse events |
Source 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/NCT00634920
GET https://conductscience.org/api/trials/v1/NCT00634920/results?page=2