Trial · NCT00514514
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| SECONDARY | GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method | 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 |
| SECONDARY | Mean Change in Serum Creatinine From Month 3 to Month 60 | From randomization at BL2 (Month 3) to Month 60 post-transplant | Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period. | mg/dl | LEAST_SQUARES_MEAN |
| SECONDARY | Efficacy Event Data After Month 12 to Month 60 | Events starting after 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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