1. LOCATION OF STUDY: Multicentric study in Brazil. 2. 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. 3. 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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
glucose sparing dialysis solution
glucose based dialysis solution
Hospital São João de Deus
Divinópolis, Minas Gerais, Brazil
Universidade Federal de Uberlândia
Uberlândia, Minas Gerais, Brazil
Clinica de Doencas Renais
Curitiba, Paraná, Brazil
Instituto do Rim de Curitiba
Curitiba, Paraná, Brazil
Nefroclinica de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Clinese
Aracaju, Sergipe, Brazil
Universidade Estadual Paulista
Botucatu, São Paulo, Brazil
Universidade Federal de Sao Paulo
São Paulo, São Paulo, Brazil
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor
Adjusted HOMA index score at 3 months using baseline values as a covariate and groups as the fixed factor. HOMA index was calculated as follows: (fasting glucose(mg/dl) x fasting serum insulin (μU/mL))/405
Time frame: 3 months
Oral Fasting Serum Glucose
Serum glucose measured in oral fasting but not peritoneal fasting. For this outcome we compared groups using analysis of covariance (ANCOVA) using the baseline values as covariate, groups as the fixed factor and the value obtained at 90 days as the dependent variable. Significance level for alpha was setting at \< 0.05.
Time frame: 3 months
Serum Insulin
Serum insulin was log-transformed to meet all criteria for ANCOVA. The baseline value was treated as covariate, groups as the fixed factor and the serum insulin at 3 months as the dependent variable. Serum insulin was measured in oral fasting by chemioluminescense.
Time frame: 3 months
Glycated Hemoglobin
Adjusted glycated hemoglobin was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of HbA1c was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable. Glycated hemoglobin was measured by high-performance liquid chromatography.
Time frame: 3 months
Total Ultrafiltration
Total ultrafiltration obtained in 24 hours was obtained and compared between groups using analysis of covariance (ANCOVA). The baseline values of total ultrafiltration was used as covariate, the groups as the fixed factor and the value obtained at 90 days as the dependent variable.
Time frame: 3 months
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