Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Peritoneal Dialysis Patients

NCT ID: NCT01021878

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-02-29

Brief 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.

Conditions

Disorders Associated With Peritoneal Dialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

icodextrin

glucose sparing alternative dialysis solution

Group Type: EXPERIMENTAL

icodextrin

Intervention Type: OTHER

glucose sparing dialysis solution

dextrose

dianeal, Control group, standard treatment

Group Type: ACTIVE_COMPARATOR

Dianeal

Intervention Type: OTHER

glucose based dialysis solution

Interventions

icodextrin

glucose sparing dialysis solution

Intervention Type: OTHER

Dianeal

glucose based dialysis solution

Intervention Type: OTHER

Other Intervention Names

Extraneal

Eligibility Criteria

Inclusion Criteria

• 1.10.1 Older than 18 years old.
• High PET value, average-high or average-low.
• Cause of renal chronic disease other than diabetes mellitus.
• Patient in APD
• Prevalent patient in APD (defined as at least 90 total days of dialysis therapy)

Exclusion Criteria

• Not willing to participate.
• A Charlson comorbidity index >7, or a life expectancy < 12 months as assessed by the treating physician.
• Positive VIH.
• Episodes of peritonitis during the month preceding the randomization.
• Significant cardiovascular, metabolic or infectious complications during the month preceding the randomization.
• Patients with active cancer.
• Patients with known allergies to corn starch polymers.
• Patients who are unable to provide an informed consent because of significant psychiatric disorder or mental illness
• Patients not meeting adequacy goals several months after the change in the dosage regime.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role: lead

Responsible Party

Roberto Pecoits-Filho

MD, PhD, FASN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Pecoits-Filho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidade Catolica do Parana

Locations

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

Countries

Brazil

Other Identifiers

PUCPR 01

Identifier Type: -

Identifier Source: org_study_id