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
Baxter Healthcare Corporation
Information provided by:
Pontifícia Universidade Católica do Paraná
ClinicalTrials.gov Identifier:
First received: November 27, 2009
Last updated: July 20, 2011
Last verified: November 2009
  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

  Show Detailed Description


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

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

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

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
Principal Investigator: Roberto Pecoits-Filho, MD, PhD Pontificia Universidade Catolica do Parana
  More 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

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014