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
  Purpose
  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.


Condition Intervention Phase
Disorders Associated With Peritoneal Dialysis
Other: icodextrin
Other: Dianeal
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pontifícia Universidade Católica do Paraná:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: icodextrin
glucose sparing alternative dialysis solution
Other: icodextrin
glucose sparing dialysis solution
Other Name: Extraneal
Active Comparator: dextrose
Control group, standard treatment
Other: Dianeal
glucose based dialysis solution
Other Name: Dianeal

  Hide Detailed Description

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021878

Contacts
Contact: Thyago Moraes, MD +55 41 84028588 thyagomoraes@hotmail.com

Locations
Brazil
Universidade Federal de Uberlândia Recruiting
Uberlândia, Minas Gerais, Brazil, 38400 089
Contact: Sebastião F Filho, MD    +55 034 91299709    ferreirafilho1952@gmail.com   
Sub-Investigator: Sebastião F Filho, MD         
Instituto do Rim de Curitiba Recruiting
Curitiba, Parana, Brazil, 80250-070
Contact: Gina Moreno, MD       givanski@hotmail.com   
Sub-Investigator: Gina Moreno, MD         
Sub-Investigator: Helio V Cassi, MD         
Clinica de Doencas Renais Recruiting
Curitiba, PR, Brazil, 80220901
Contact: Priscila Demetrio, Pharm    +55 41 32713150    priscilahd@gmail.com   
Principal Investigator: Thyago Moraes, MD         
Nefroclinica de Caxias do Sul Recruiting
Caxias do Sul, Rio Grande do Sul, Brazil, 95010-003
Contact: Dirceu R Silva, MD       dirceucx@terra.com.br   
Sub-Investigator: Dirceu R Silva, MD         
Universidade Estadual Paulista Recruiting
Botucatu, Sao Paulo, Brazil, 18618970
Contact: Jacqueline T Caramori, phD    +55 14 38116143    jteixeir@fmb.unesp.br   
Sub-Investigator: Jacqueline CT Caramori, phD         
Instituto do Rim de Marília Withdrawn
Marilia, Sao Paulo, Brazil, 17515-280
Clinese Recruiting
Aracaju, Sergipe, Brazil, 49075210
Contact: Ubiratania Machado, MD       tania@clinese.com.br   
Sub-Investigator: Kleyton A Bastos, MD         
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, Brazil, 04023 062
Contact: Suellen A Gonzales, Mrs    +55 11 5904-8499    suellengonzales@hrim.com.br   
Sub-Investigator: Maria Eugênia F Canziani, phD         
Sponsors and Collaborators
Pontifícia Universidade Católica do Paraná
Baxter Healthcare Corporation
Investigators
Principal Investigator: Roberto Pecoits-Filho, MD, PhD Pontificia Universidade Catolica do Parana
  More Information

Additional Information:
No publications provided

Responsible Party: Roberto Pecoits-Filho, PUCPR
ClinicalTrials.gov Identifier: NCT01021878     History of Changes
Other Study ID Numbers: PUCPR 01
Study First Received: November 27, 2009
Last Updated: July 20, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Pontifícia Universidade Católica do Paraná:
Peritoneal dialysis
Renal replacement therapy
Dialysis solutions
Icodextrin

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014