A Study to Evaluate the Effects of Icodextrin Versus 2.5% Dianeal on Insulin Resistance in Non Diabetic Apd Patients (STARCH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Pontifícia Universidade Católica do Paraná.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
NCT01021878
First received: November 27, 2009
Last updated: July 20, 2011
Last verified: November 2009

November 27, 2009
July 20, 2011
October 2009
November 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01021878 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effects of Icodextrin Versus 2.5% Dianeal on Insulin Resistance in Non Diabetic Apd 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 glycated hemoglobin 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 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.

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 GLYCATED HEMOGLOBIN 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 glycated hemoglobin 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 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.

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).

1.6.2 Secondary outcomes were efficacy and cost-effectivity, measured by:

  • Daily UF.
  • Long-dwell UF.
  • Serum lipids.
  • MEDTRONIC Continuous subcutaneous glucose monitoring system.
  • Body Mass Index.
  • Dry weight.
  • Systolic arterial pressure.
  • Diastolic arterial pressure.
  • Serum albumin.
  • Total protein.
  • Subjective Global Assessment (SGA).
  • Number of hospitalization events.
  • Time until hospitalization.
  • Time of hospitalization.
  • Time to peritonitis.
  • Program withdrawal ratios between the two groups.
  • Number of antihypertensive drugs.
  • Cost per type of therapy.
  • Cost of antihypertensive drugs.
  • Health-related quality of life.
  • Malnutrition-inflammation score.
  • Protein equivalent of nitrogen appearance (PNA )

1.6.3 EXPLORATORY OUTCOMES

  • Insulin levels.
  • Adipocytokines.
  • C-peptide.
  • Leptin.
  • Resistin
  • Fructosamine
  • Advanced Glycation End-products (AGEs)
  • Hs CRP
  • Interleukin-6
  • Fibrinogen
  • Icodextrin metabolites.

1.6.4 The incidence of adverse events will be measured as a safety outcome. In addition, solute transport in the peritoneal membrane will be assessed at the end of the follow-up period.

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
    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.
 
Recruiting
120
November 2011
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: Thyago Moraes, MD +55 41 84028588 thyagomoraes@hotmail.com
Brazil
 
NCT01021878
PUCPR 01
Yes
Roberto Pecoits-Filho, PUCPR
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
November 2009

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