Trial · NCT00514514
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
NCT00514514, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen. Trials, record NCT00514514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514514
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
- NCT number
- NCT00514514
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 802 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Kidney Transplantation
- Interventions
- Everolimus, Myfortic, Sandimmun Optoral, Simulect®
- First posted
- 2007-08-10
- Last updated
- 2017-01-18
- Results first posted
- 2017-01-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen | From randomization at BL2 (Month 3) to Month 12 post-transplant | Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted |
| Secondary | GFR Via Nankivell Formula at Month 12 - All Regimens | From randomization at BL2 (Month 3) to Month 12 post-transplant | Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. |
| Secondary | GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method | From randomization at BL2 (Month 3) to Month 12 post-transplant | Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat: For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. |
| Secondary | GFR at Month 12 Utilizing Cockcroft-Gault Formula | From randomization at BL2 (Month 3) to Month 12 post-transplant | Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model |
| Secondary | Mean Change in Serum Creatinine From Month 3 to Month 12 | From randomization at BL2 (Month 3) to Month 12 post-transplant | Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model |
| Secondary | Efficacy Event Data From Baseline 2 (Month 3) to Month 6 | From Baseline 2 (Month 3) to Month 6 | Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity). |
| Secondary | Efficacy Event Data Baseline 2 (Month 3) to Month 12 | From Baseline 2 (Month 3) to Month 12 | Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity). |
| Secondary | Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk) | From Baseline 2 (Month 3) to Month 12 | The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years. |
| Secondary | GFR Calculated Via Nankivell Formula at Month 60 | From randomization at BL2 (Month 3) to Month 60 | Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. |
| Secondary | GFR at Month 60 Utilizing Cockcroft-Gault Formula | From randomization at BL2 (Month 3) to Month 60 post-transplant | Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen | From randomization at BL2 (Month 3) to Month 12 post-transplant | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization. | ml/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | GFR Via Nankivell Formula at Month 12 - All Regimens | From randomization at BL2 (Month 3) to Month 12 post-transplant | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization. | ml/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method | From randomization at BL2 (Month 3) to Month 12 post-transplant | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization. | ml/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | GFR at Month 12 Utilizing Cockcroft-Gault Formula | From randomization at BL2 (Month 3) to Month 12 post-transplant | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization. | ml/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Serum Creatinine From Month 3 to Month 12 | From randomization at BL2 (Month 3) to Month 12 post-transplant | Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization | mg/dl | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy Event Data From Baseline 2 (Month 3) to Month 6 | From Baseline 2 (Month 3) to Month 6 | The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization. | Participants | NUMBER |
| SECONDARY | Efficacy Event Data Baseline 2 (Month 3) to Month 12 | From Baseline 2 (Month 3) to Month 12 | The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization. | Participants | NUMBER |
| SECONDARY | Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk) | From Baseline 2 (Month 3) to Month 12 | The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization. | Percent risk | MEAN |
| SECONDARY | GFR Calculated Via Nankivell Formula at Month 60 | From randomization at BL2 (Month 3) to Month 60 | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization | ml/min/1.73m² | LEAST_SQUARES_MEAN |
| SECONDARY | GFR at Month 60 Utilizing Cockcroft-Gault Formula | From randomization at BL2 (Month 3) to Month 60 post-transplant | Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization | ml/min/1.73m² | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen | Standard Regimen | 63.03 | 95% Confidence Interval 60.57 to 65.49 | ml/min/1.73m² | |
| GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen | CNI Free Regimen | 68.59 | 95% Confidence Interval 66.10 to 71.08 | ml/min/1.73m² | |
| GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen | CNI Low Regimen | 63.08 | 95% Confidence Interval 60.62 to 65.55 | ml/min/1.73m² | |
| GFR Via Nankivell Formula at Month 12 - All Regimens | Standard Regimen | 63.03 | 95% Confidence Interval 60.57 to 65.49 | ml/min/1.73m² | |
| GFR Via Nankivell Formula at Month 12 - All Regimens | CNI Free Regimen | 68.59 | 95% Confidence Interval 66.10 to 71.08 | ml/min/1.73m² | |
| GFR Via Nankivell Formula at Month 12 - All Regimens | CNI Low Regimen | 63.08 | 95% Confidence Interval 60.62 to 65.55 | ml/min/1.73m² | |
| GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method | Standard Regimen | 50.23 | 95% Confidence Interval 47.66 to 52.80 | ml/min/1.73m² | |
| GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method | CNI Free Regimen | 56.36 | 95% Confidence Interval 53.77 to 58.94 | ml/min/1.73m² | |
| GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method | CNI Low Regimen | 50.24 | 95% Confidence Interval 47.70 to 52.77 | ml/min/1.73m² | |
| GFR at Month 12 Utilizing Cockcroft-Gault Formula | Standard Regimen | 60.18 | 95% Confidence Interval 57.33 to 63.03 | ml/min/1.73m² |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow33
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-phase | STARTED | Standard Regimen | 802 | |
| Pre-phase | STARTED | CNI Free Regimen | 0 | |
| Pre-phase | STARTED | CNI Low Regimen | 0 | |
| Pre-phase | COMPLETED | Standard Regimen | 499 | |
| Pre-phase | COMPLETED | CNI Free Regimen | 0 | |
| Pre-phase | COMPLETED | CNI Low Regimen | 0 | |
| Pre-phase | NOT COMPLETED | Standard Regimen | 303 | |
| Pre-phase | NOT COMPLETED | CNI Free Regimen | 0 | |
| Pre-phase | NOT COMPLETED | CNI Low Regimen | 0 | |
| Randomized - 9 Month | STARTED | Standard Regimen | 166 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 participant flowAdverse events732
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 | Standard Regimen | 5 | 165 | |
| other | ANAEMIA | Blood and lymphatic system disorders | CNI-free | 14 | 171 | |
| other | ANAEMIA | Blood and lymphatic system disorders | CNI-low | 2 | 161 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Standard Regimen | 22 | 165 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | CNI-free | 26 | 171 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | CNI-low | 18 | 161 | |
| other | APHTHOUS STOMATITIS | Gastrointestinal disorders | Standard Regimen | 1 | 165 | |
| other | APHTHOUS STOMATITIS | Gastrointestinal disorders | CNI-free | 33 | 171 | |
| other | APHTHOUS STOMATITIS | Gastrointestinal disorders | CNI-low | 14 | 161 | |
| other | DIARRHOEA | Gastrointestinal disorders | Standard Regimen | 17 | 165 |
1 to 10 of 732Source ClinicalTrials.gov
See all 732 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Regimen | ||
| Total, all-cause mortality | CNI-free | ||
| Total, all-cause mortality | CNI-low | ||
| Total, other adverse events | Standard Regimen | 121 | 165 |
| Total, other adverse events | CNI-free | 134 | 171 |
| Total, other adverse events | CNI-low | 133 | 161 |
| Total, serious adverse events | Standard Regimen | 87 | 165 |
| Total, serious adverse events | CNI-free | 91 | 171 |
| Total, serious adverse events | CNI-low | 85 | 161 |
Source ClinicalTrials.gov
Papers2
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/NCT00514514
GET https://conductscience.org/api/trials/v1/NCT00514514/results?page=2