Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients
Condition: Disorders Associated With Peritoneal Dialysis
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): icodextrin; Dianeal
Intervention type(s): Other; Other
Intervention description(s): glucose sparing dialysis solution; glucose based dialysis solution
Other intervention name(s): Extraneal
Intervention MeSH terms: Icodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peritoneal dialysis; Renal replacement therapy; Dialysis solutions; Icodextrin