1. SUMMARY OF THE STUDY~1.1 PROTOCOLE TITLE : A RANDOMIZED, OPEN-LABEL CLINICAL TRIAL TO EVALUATE THE EFFECTS OF ICODEXTRIN Vs 2,5% DIANEAL USED FOR THE LONG-DWELL ON HOMA INDEX IN PREVALENT, NON-DIABETIC, PATIENTS IN AUTOMATED PERITONEAL DIALYSIS (APD)~1.2 MAIN RESEARCHERS: Roberto Pecoits Filho, Thyago P. Moraes~1.3 LOCATION OF STUDY: Multicentric study in Brazil.~1.4 PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell.~1.5 PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism.~1.6 SECONDARY OUTCOMES:~1.6.1 Other efficacy outcomes were total UF, long-dwell UF, and preprandial glycemia (taken first in the morning before breakfast), serum insulin levels and glycated haemoglobin.~1.6.2 The incidence of adverse events will be measured as a safety outcome.~1.7 STAGE OF THE STUDY : Phase IV postmarket study~1.8 DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.~1.9 SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 100 60 ExtranealTM 50 30 Dianeal® 50 30~1.12 PHARMACEUTICAL FORM, ROUTE OF DE ADMINISTRATION AND DOSAGE~ExtranealTM (7.5% Icodextrin) solution for Peritoneal Dialysis:~It is labelled as solution for dialysis to be administered within the study for a period of one (1) year.~Available in 2 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.~Dianeal® PD4 (2.5% Dextrose) solution for Peritoneal Dialysis:~It is labelled as 2.27% glucose-based solution for dialysis, to be administered within the study for a period of one (1) year.~Available in 2 and 2.5 liter bags of peritoneal dialysis solution (Twin Bag) for CAPD, this product will be used during the long-dwell.~Duration: 1 year.
LOCATION OF STUDY: Multicentric study in Brazil.~PURPOSE OF THE STUDY: To measure changes in HOMA index when non-diabetic patients in APD were exposed to 7,5% Icodextrin for the long-dwell; and to compare such changes with those produced by 2,5% glucose for the long-dwell.~PRIMARY OUTCOME: The primary efficacy outcome was to measure HOMA index to set the differences with regard to baseline values of this variable for the two groups as well as in each group, which showed control of the glucose metabolism.~STAGE OF THE STUDY : Phase IV postmarket study~DESIGN: Randomized, open-label, multicenter study. Patients were randomized to receive either to Extraneal (7,5% Icodextrin) or 2.5% Dianeal during the long-dwell.~SAMPLE SIZE: Randomization Upon completion of the study TOTAL: 120 60 ExtranealTM 60 30 Dianeal® 60 30~Duration: 1 year.