| Outcome Measures: |
Primary: Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF), The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis., 9 months | Secondary: Assessment of GFR by the Cockcroft-Gault Method (LOCF), the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight\[kg\]/72X Serum Creatinine\[mg/dl\] For women: GFR= 0,85x(140-Age) x Body Weight\[kg\]/72x Serum Creatinine \[mg/dl\] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis., 9 months|Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death., Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss., 9 months|Participants Who Had Occurrence of Treatment Failure., Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen., 9 months|Change in Renal Function (Creatinine Slope), X(slope)=(1/value of creatinine)., 3 months, 5 months, 7 months, 9 months
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| Locations: |
Novartis Investigative Site, Haifa, 31096, Israel|Novartis Investigative Site, Petach Tikva, 49100, Israel|Novartis Investigative Site, Tel-Aviv, 64239, Israel
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