NCT01021878

Brief Summary

  1. 1.LOCATION OF STUDY: Multicentric study in Brazil.
  2. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2009

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 1, 2014

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

November 27, 2009

Results QC Date

June 24, 2014

Last Update Submit

September 30, 2014

Conditions

Disorders Associated With Peritoneal Dialysis

Keywords

Peritoneal dialysisRenal replacement therapyDialysis solutionsIcodextrin

Outcome Measures

Primary Outcomes (1)

  • Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor

    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

    3 months

Secondary Outcomes (4)

  • Oral Fasting Serum Glucose

    3 months

  • Serum Insulin

    3 months

  • Glycated Hemoglobin

    3 months

  • Total Ultrafiltration

    3 months

Study Arms (2)

icodextrin

EXPERIMENTAL

glucose sparing alternative dialysis solution

Other: icodextrin

dextrose

ACTIVE COMPARATOR

dianeal, Control group, standard treatment

Other: Dianeal

Interventions

icodextrinOTHER

glucose sparing dialysis solution

Also known as: Extraneal
icodextrin
DianealOTHER

glucose based dialysis solution

dextrose

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital São João de Deus

Divinópolis, Minas Gerais, Brazil

Location

Universidade Federal de Uberlândia

Uberlândia, Minas Gerais, 38400 089, Brazil

Location

Clinica de Doencas Renais

Curitiba, Paraná, 80220901, Brazil

Location

Instituto do Rim de Curitiba

Curitiba, Paraná, 80250-070, Brazil

Location

Nefroclinica de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, 95010-003, Brazil

Location

Clinese

Aracaju, Sergipe, 49075210, Brazil

Location

Universidade Estadual Paulista

Botucatu, São Paulo, 18618970, Brazil

Location

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023 062, Brazil

Location

MeSH Terms

Interventions

Icodextrin

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Roberto Pecoits-Filho and Dr. Thyago P. Moraes
Organization
Pontifícia Universidade Católica do Paraná
r.pecoits@pucpr.br
554132713150

Study Officials

  • Roberto Pecoits-Filho, MD, PhD

    Pontificia Universidade Catolica do Parana

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FASN

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

October 1, 2014

Results First Posted

October 1, 2014

Record last verified: 2014-09

Locations

BR(8)