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

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

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.

Study Overview

• Status: Completed
• Conditions: Disorders Associated With Peritoneal Dialysis
• Intervention / Treatment: Other: icodextrin; Other: Dianeal

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 04023 062
    • Universidade Federal de São Paulo
  • MG
    • Divinópolis, MG, Brazil
      • Hospital São João de Deus
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38400 089
      • Universidade Federal de Uberlândia
  • PR
    • Curitiba, PR, Brazil, 80220901
      • Clinica de Doencas Renais
  • Parana
    • Curitiba, Parana, Brazil, 80250-070
      • Instituto do Rim de Curitiba
  • Rio Grande do Sul
    • Caxias do Sul, Rio Grande do Sul, Brazil, 95010-003
      • Nefroclinica de Caxias do Sul
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618970
      • Universidade Estadual Paulista
  • Sergipe
    • Aracaju, Sergipe, Brazil, 49075210
      • Clinese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: icodextrin; glucose sparing alternative dialysis solution	Other: icodextrin; glucose sparing dialysis solution; Other Names: Extraneal
ACTIVE_COMPARATOR: dextrose; dianeal, Control group, standard treatment	Other: Dianeal; glucose based dialysis solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pontifícia Universidade Católica do Paraná
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Roberto Pecoits-Filho, MD, PhD, Pontifícia Universidade Católica do Paraná

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: November 27, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (ESTIMATE): November 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 1, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Peritoneal dialysis; Icodextrin; Dialysis solutions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Pharmaceutical Solutions; Dialysis Solutions; Icodextrin
• Other Study ID Numbers: PUCPR 01