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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01021878
First received: November 27, 2009
Last updated: September 30, 2014
Last verified: September 2014

November 27, 2009
September 30, 2014
October 2009
November 2011   (final data collection date for primary outcome measure)
Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

The primary efficacy outcome was to measure glycated hemoglobin 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021878 on ClinicalTrials.gov Archive Site
  • Oral Fasting Serum Glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
  • Serum lipids. Serum albumin. Total protein. Subjective Global Assessment (SGA). Number of hospitalization events. Time until hospitalization. Time of hospitalization. Number of antihypertensive drugs. Cost per type of therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Other efficacy outcomes were total UF, long-dwell UF, and preprandial glycemia (taken first in the morning before breakfast). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
  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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Disorders Associated With Peritoneal Dialysis
  • Other: icodextrin
    glucose sparing dialysis solution
    Other Name: Extraneal
  • Other: Dianeal
    glucose based dialysis solution
    Other Name: Dianeal
  • Experimental: icodextrin
    glucose sparing alternative dialysis solution
    Intervention: Other: icodextrin
  • Active Comparator: dextrose
    dianeal, Control group, standard treatment
    Intervention: Other: Dianeal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01021878
PUCPR 01
Yes
Roberto Pecoits-Filho, Pontifícia Universidade Católica do Paraná
Pontifícia Universidade Católica do Paraná
Baxter Healthcare Corporation
Principal Investigator: Roberto Pecoits-Filho, MD, PhD Pontificia Universidade Catolica do Parana
Pontifícia Universidade Católica do Paraná
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP