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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01021878

Acronym

STARCH

Enrollment

Registered

2009-11-30

Start date

2009-10-31

Completion date

2012-02-29

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders Associated With Peritoneal Dialysis

Keywords

Peritoneal dialysis, Renal replacement therapy, Dialysis solutions, Icodextrin

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.

Interventions

OTHERicodextrin

glucose sparing dialysis solution

OTHERDianeal

glucose based dialysis solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor	3 months	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

Secondary

Measure	Time frame	Description
Oral Fasting Serum Glucose	3 months	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.
Serum Insulin	3 months	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.
Glycated Hemoglobin	3 months	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.
Total Ultrafiltration	3 months	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.

Countries

Brazil

Participant flow

Participants by arm

Arm	Count
Icodextrin glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution	33
Dextrose Control group, standard treatment Dianeal: glucose based dialysis solution	27
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	6	5
Overall Study	Death	0	1
Overall Study	Lost to Follow-up	4	3
Overall Study	Transplantation	6	1

Baseline characteristics

Characteristic	Icodextrin	Dextrose	Total
Age, Continuous	50.1 years STANDARD_DEVIATION 15.5	54.1 years STANDARD_DEVIATION 17.4	52.1 years STANDARD_DEVIATION 16.45
HOMA index	2.10 IR score STANDARD_DEVIATION 1.1	1.77 IR score STANDARD_DEVIATION 1	1.95 IR score STANDARD_DEVIATION 1.05
Region of Enrollment Brazil	33 participants	27 participants	60 participants
Sex: Female, Male Female	18 Participants	15 Participants	33 Participants
Sex: Female, Male Male	15 Participants	12 Participants	27 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 33	1 / 27
serious Total, serious adverse events	4 / 33	5 / 27

Arm	Measure	Value (MEAN)
Icodextrin	Total Ultrafiltration	958 millilitre
Dextrose	Total Ultrafiltration	656 millilitre

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026