Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
Trial · NCT01950819
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. | Month 12 is Primary, Month 24 secondary | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | Baseline (week 4), Month 12 and 24 | full analysis set | mL/min/1.73m2 | MEAN |
| SECONDARY | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | Month 12 and 24 | full analysis set | mL / min / 1.73m2 / day | MEAN |
| SECONDARY | Renal Function Assessed by Creatinine Lab Values | Month 12 and 24 | full analysis set with measure | micromol/L | MEAN |
| SECONDARY | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | Month 12 and 24 | full analysis set with measure | mL/min/1.73m2 | MEAN |
| SECONDARY | Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | Month 24 | safety set 24 months analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events. | Month 24 | safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | Baseline, Month 12 and 24 | safety set with measure | mg/g | MEAN |
| SECONDARY | Incidence of Major Cardiovascular Events. | Month 24 | safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Malignancies. | Month 24 | safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects. | Month 12 and 24 | compliance set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | Month 12 and 24 | full analysis set | events | NUMBER |
| SECONDARY | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | Month 12 and 24 | full analysis set | Participants | COUNT_OF_PARTICIPANTS |
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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