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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| icodextrin | Experimental | glucose sparing alternative dialysis solution |
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| dextrose | Active Comparator | dianeal, Control group, standard treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| icodextrin | Other | glucose sparing dialysis solution |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Pecoits-Filho, MD, PhD | Pontificia Universidade Catolica do Parana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São João de Deus | Divinópolis | Minas Gerais | Brazil | |||
| Universidade Federal de Uberlândia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Icodextrin | glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution N=33 |
| FG001 | Dextrose | Control group, standard treatment Dianeal: glucose based dialysis solution N=27 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dianeal | Other | glucose based dialysis solution |
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| 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. | 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. | 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. | 3 months |
| Uberlândia |
| Minas Gerais |
| 38400 089 |
| Brazil |
| Clinica de Doencas Renais | Curitiba | Paraná | 80220901 | Brazil |
| Instituto do Rim de Curitiba | Curitiba | Paraná | 80250-070 | Brazil |
| Nefroclinica de Caxias do Sul | Caxias do Sul | Rio Grande do Sul | 95010-003 | Brazil |
| Clinese | Aracaju | Sergipe | 49075210 | Brazil |
| Universidade Estadual Paulista | Botucatu | São Paulo | 18618970 | Brazil |
| Universidade Federal de Sao Paulo | São Paulo | São Paulo | 04023 062 | Brazil |
| Completed Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Icodextrin | glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution |
| BG001 | Dextrose | Control group, standard treatment Dianeal: glucose based dialysis solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HOMA index | Mean | Standard Deviation | IR score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Mean | 95% Confidence Interval | IR score | 3 months |
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| Secondary | 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. | Mean | 95% Confidence Interval | mg/dl | 3 months |
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| Secondary | 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. | Mean | 95% Confidence Interval | log(mmol/L) | 3 months |
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| Secondary | 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. | Mean | 95% Confidence Interval | percentage of haemoglobin | 3 months |
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| Secondary | 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. | Mean | 95% Confidence Interval | millilitre | 3 months |
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3 months
Patients were trained to report adverse effects immediately. Otherwise, adverse effects were checked every other week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icodextrin | glucose sparing alternative dialysis solution icodextrin: glucose sparing dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group. | 4 | 33 | 1 | 33 | ||
| EG001 | Dextrose | Control group, standard treatment Dianeal: glucose based dialysis solution There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group. | 5 | 27 | 1 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Systematic Assessment | Sepsis |
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| Peritonitis | Infections and infestations | Systematic Assessment | Peritonitis related to Peritoneal dialysis |
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| Exit-site infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ultrafiltration Failure | General disorders | Systematic Assessment |
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| Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| gastroesophageal reflux | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roberto Pecoits-Filho and Dr. Thyago P. Moraes | Pontifícia Universidade Católica do Paraná | 554132713150 | r.pecoits@pucpr.br |
| ID | Term |
|---|---|
| D000077607 | Icodextrin |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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