A Phase 4 interventional study of icodextrin and Dianeal in Disorders Associated With Peritoneal Dialysis, sponsored by Pontifícia Universidade Católica do Paraná. Completed at 8 sites in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-10-01.
Sponsored by Pontifícia Universidade Católica do Paraná · Phase 4, Interventional, and Treatment
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.
1.1 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.
1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Pontifícia Universidade Católica do Paraná is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
glucose sparing alternative dialysis solution
Other: icodextrin
dianeal, Control group, standard treatment
Other: Dianeal
glucose sparing dialysis solution
Also known as: Extraneal
glucose based dialysis solution
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
Time frame: 3 months
Oral Fasting Serum Glucose
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.
Time frame: 3 months
Serum Insulin
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.
Time frame: 3 months
Glycated Hemoglobin
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.
Time frame: 3 months
Total Ultrafiltration
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.
Time frame: 3 months
| Milestone | Icodextrin | Dextrose |
|---|---|---|
| Started | 33 | 27 |
| Completed follow-up | 17 | 17 |
| Completed | 17 | 17 |
| Not completed | 16 | 10 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Adverse event | 6 | 5 |
| Withdrew: Transplantation | 6 | 1 |
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
| IR score | Icodextrin | Dextrose |
|---|---|---|
| Adjusted HOMA Index Score at 3 Months Using Baseline Values as a Covariate and Groups as the Fixed Factor | 1.49 (1.23 to 1.74) | 1.89 (1.62 to 2.17) |
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.
| mg/dl | Icodextrin | Dextrose |
|---|---|---|
| Oral Fasting Serum Glucose | 92.8 ± 20.0 | 94.5 ± 17.9 |
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.
| log(mmol/L) | Icodextrin | Dextrose |
|---|---|---|
| Serum Insulin | 0.79 (0.70 to 0.87) | 0.90 (0.81 to 0.98) |
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.
| percentage of haemoglobin | Icodextrin | Dextrose |
|---|---|---|
| Glycated Hemoglobin | 4.97 (4.73 to 5.21) | 4.86 (4.62 to 5.10) |
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.
| millilitre | Icodextrin | Dextrose |
|---|---|---|
| Total Ultrafiltration | 958 (818 to 1097) | 656 (517 to 795) |
Collected over 3 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Icodextrin | — | 4/33 (12.1%) | 1/33 (3%) |
| Dextrose | — | 5/27 (18.5%) | 1/27 (3.7%) |
| Event | Icodextrin | Dextrose |
|---|---|---|
| PeritonitisInfections and infestations | 2/33 | 2/27 |
| Exit-site infectionSkin and subcutaneous tissue disorders | 2/33 | 2/27 |
| DeathInfections and infestations | 0/33 | 1/27 |
| Event | Icodextrin | Dextrose |
|---|---|---|
| Ultrafiltration FailureGeneral disorders | 0/33 | 1/27 |
| HerniaMusculoskeletal and connective tissue disorders | 1/33 | 0/27 |
| gastroesophageal refluxGastrointestinal disorders | 1/33 | 0/27 |
From October 2009 to February 2012 60 patients were randomly assigned to the intervention (n=33) or the control (n=27) group. Completed follow-up was achieved for 34 patients, of which 17 of the control and 17 of the study group.
| Age, Continuous(years) | Icodextrin | Dextrose | Total |
|---|---|---|---|
| Median | 50.1 ± 15.5 | 54.1 ± 17.4 | 52.1 ± 16.45 |
| Sex: Female, Male(Participants) | Icodextrin | Dextrose | Total |
|---|---|---|---|
| Female | 18 | 15 | 33 |
| Male | 15 | 12 | 27 |
| Region of Enrollment(participants) | Icodextrin | Dextrose | Total |
|---|---|---|---|
| Brazil | 33 | 27 | 60 |
| HOMA index(IR score) | Icodextrin | Dextrose | Total |
|---|---|---|---|
| Mean | 2.10 ± 1.10 | 1.77 ± 1.00 | 1.95 ± 1.05 |
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Pontifícia Universidade Católica do Paraná