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

Disorders Associated With Peritoneal Dialysis Clinical Trial

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Official title:

A Study to Evaluate the Effects of Icodextrin vs 2.5% Dianeal Used for the Long Dwell in Apd: a Randomized, Open-label Clinical Trial to Analyse the Insulin Resistance Using the Homa Index in Prevalent, Non-diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021878
• Other study ID #: PUCPR 01
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2009
• Last updated: September 30, 2014
• Start date: October 2009
• Est. completion date: February 2012

Study information

• Verified date: September 2014
• Source: Pontifícia Universidade Católica do Paraná
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorders Associated With Peritoneal Dialysis
• Insulin Resistance

Intervention

Other:
• icodextrin
glucose sparing dialysis solution
• Dianeal
glucose based dialysis solution

Locations

Country	Name	City	State
Brazil	Clinese	Aracaju	Sergipe
Brazil	Universidade Estadual Paulista	Botucatu	Sao Paulo
Brazil	Nefroclinica de Caxias do Sul	Caxias do Sul	Rio Grande do Sul
Brazil	Clinica de Doencas Renais	Curitiba	PR
Brazil	Instituto do Rim de Curitiba	Curitiba	Parana
Brazil	Hospital São João de Deus	Divinópolis	MG
Brazil	Universidade Federal de Sao Paulo	Sao Paulo
Brazil	Universidade Federal de Uberlândia	Uberlândia	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Pontifícia Universidade Católica do Paraná	Baxter Healthcare Corporation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No
Secondary	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.	3 months	No