Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
Trial · NCT01950819
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) \< 50 mL/min/1.73m2. |
| Secondary | Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death | Month 12 and 24 | Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death |
| Secondary | Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR \< 50 mL/min/1.73m2 |
| Secondary | Incidence of Failure on the Composite Endpoint of Graft Loss or Death. | Month 12 and 24 | Incidence of failure on the composite endpoint of graft loss or death. |
| Secondary | Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection | Month 12 and 24 | Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection) |
| Secondary | Incidence of eGFR < 50 mL/Min/1.73m2 | Month 12 and 24 | Incidence of eGFR \< 50 mL/min/1.73m2 |
| Secondary | Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR | Baseline (week 4), Month 12 and 24 | Renal allograft function : mean estimated glomerular filtration rate, eGFR |
| Secondary | Evolution of Renal Function, as eGFR, Over Time by Slope Analysis. | Month 12 and 24 | Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates. |
| Secondary | Renal Function Assessed by Creatinine Lab Values | Month 12 and 24 | Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis. |
| Secondary | Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported | Month 12 and 24 | Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis. |
| Secondary | Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation. | Month 24 | Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation. |
| 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 | Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events. |
| Secondary | Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios. | Baseline, Month 12 and 24 | Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios. |
| Secondary | Incidence of Major Cardiovascular Events. | Month 24 | Incidence of major cardiovascular events by Preferred Term |
| Secondary | Incidence of Malignancies. | Month 24 | Incidence of malignancies. |
| 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 | 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. |
| Secondary | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants) | Month 12 and 24 | Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity: * Type IA - Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IB - Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IIA - Mild to moderate intimal arteritis * Type IIB - Severe intimal arteritis comprising \> 25% of the lumenal area * Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation) |
| Secondary | Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events) | Month 12 and 24 | Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity: * Type IA - Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IB - Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IIA - Mild to moderate intimal arteritis * Type IIB - Severe intimal arteritis comprising \> 25% of the lumenal area * Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation) |
| Secondary | Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections | Month 12 and 24 | Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity: * Type IA - Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IB - Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). * Type IIA - Mild to moderate intimal arteritis * Type IIB - Severe intimal arteritis comprising \> 25% of the lumenal area * Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation) |
| Secondary | Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup | Month 12 and 24 | Incidence of composite of tBPAR or eGRF\<50 mL/min/1.73m2 by subgroup |
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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