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Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients (EDEN)

Primary Purpose

End Stage Renal Disease (ESRD), Diabetes, CAPD

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Dianeal
Dianeal, Extraneal, Nutrineal
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD) focused on measuring ESRD, Diabetes, CAPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female patients 18 years of age or older
  2. Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min]
  3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
  4. Diabetes Mellitus (Type 1 and 2)
  5. HbA1c > 6.0% but ≤ 12.0%
  6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
  7. Total Kt/V ≥ 1.7

Exclusion Criteria:

  1. Blood Urea Nitrogen (BUN) > 95 mg/dL
  2. Exposure to Extraneal within 60 days of Screening
  3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at Screening
  4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
  5. Cardiovascular event within the last 30 days
  6. Ongoing clinically significant congestive heart failure [New York Heart Association (NYHA) class III or IV]
  7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
  8. Receiving rosiglitazone maleate

Sites / Locations

  • Nefrosalud Ltda
  • RTS Ltda Barranquila
  • RTS Ltda Soledad
  • Rts Ltda Ag H.U.S
  • RTS Ltda H.U.V
  • RTS Ltda STR del Valle
  • RTS Ltda Versalles
  • Renal Therapy Services (RTS) Ltda Cartagena
  • RTS Ltda Cucuta
  • RTS Ltda Girardot
  • Unidad Renal de Tolima
  • RTS Ltda Sucursal Medellin
  • RTS Ltda Valle de Aburra
  • RTS Ltda Sogamoso
  • RTS Sucrusal Tulua
  • RTS Ltda Villavicencio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-glucose Sparing

Glucose Sparing

Arm Description

Dianeal only

Dianeal, Extraneal, Nutrineal

Outcomes

Primary Outcome Measures

Change From the Baseline Value in HbA1c at Month 3 and 6
HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Secondary Outcome Measures

Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.
Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of MRI Body Composition at Month 6
Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.

Full Information

First Posted
October 8, 2010
Last Updated
February 20, 2019
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01219959
Brief Title
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Acronym
EDEN
Official Title
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD), Diabetes, CAPD
Keywords
ESRD, Diabetes, CAPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-glucose Sparing
Arm Type
Active Comparator
Arm Description
Dianeal only
Arm Title
Glucose Sparing
Arm Type
Experimental
Arm Description
Dianeal, Extraneal, Nutrineal
Intervention Type
Drug
Intervention Name(s)
Dianeal
Intervention Description
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose
Intervention Type
Drug
Intervention Name(s)
Dianeal, Extraneal, Nutrineal
Intervention Description
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin
Primary Outcome Measure Information:
Title
Change From the Baseline Value in HbA1c at Month 3 and 6
Description
HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Secondary Outcome Measure Information:
Title
Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
Description
This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Number of Severe Hypoglycemic Event Requiring Medical Intervention
Description
Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.
Time Frame
Baseline through Month 6 (End of Study)
Title
Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Description
Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Description
Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
Description
Values for Insulin and C-peptide are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Description
Values for Pro-Insulin are provided. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Description
Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished.
Time Frame
Baseline and Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Description
Values for Albumin and Total Protein are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Description
Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Description
Values for Pre-albumin are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Description
Values for Drained Body Weight are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Description
Values for BMI are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Description
Values for Waist Circumference are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 6 (End of Study)
Title
Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Description
Values for Protein and Calories are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
Description
European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Description
Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
Description
The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 3, Month 6 (End of Study)
Title
Change From Baseline of MRI Body Composition at Month 6
Description
Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 6 (End of Study)
Title
Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Description
Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 6 (End of Study)
Title
Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Description
Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 6 (End of Study)
Title
Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Description
Values for Left Ventricular (LV) Ejection Fraction are included. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
Time Frame
Baseline, Month 6 (End of Study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female patients 18 years of age or older Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min] CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time Diabetes Mellitus (Type 1 and 2) HbA1c > 6.0% but ≤ 12.0% Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL Total Kt/V ≥ 1.7 Exclusion Criteria: Blood Urea Nitrogen (BUN) > 95 mg/dL Exposure to Extraneal within 60 days of Screening Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at Screening Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days Cardiovascular event within the last 30 days Ongoing clinically significant congestive heart failure [New York Heart Association (NYHA) class III or IV] Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance Receiving rosiglitazone maleate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call central contact for information
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Nefrosalud Ltda
City
Armenia
Country
Colombia
Facility Name
RTS Ltda Barranquila
City
Barranquila
Country
Colombia
Facility Name
RTS Ltda Soledad
City
Bogota
Country
Colombia
Facility Name
Rts Ltda Ag H.U.S
City
Bucaramanga
Country
Colombia
Facility Name
RTS Ltda H.U.V
City
Cali
Country
Colombia
Facility Name
RTS Ltda STR del Valle
City
Cali
Country
Colombia
Facility Name
RTS Ltda Versalles
City
Cali
Country
Colombia
Facility Name
Renal Therapy Services (RTS) Ltda Cartagena
City
Cartagena
Country
Colombia
Facility Name
RTS Ltda Cucuta
City
Cucuta
Country
Colombia
Facility Name
RTS Ltda Girardot
City
Girardot
Country
Colombia
Facility Name
Unidad Renal de Tolima
City
Ibague
Country
Colombia
Facility Name
RTS Ltda Sucursal Medellin
City
Medellin
Country
Colombia
Facility Name
RTS Ltda Valle de Aburra
City
Medellin
Country
Colombia
Facility Name
RTS Ltda Sogamoso
City
Sogamoso
Country
Colombia
Facility Name
RTS Sucrusal Tulua
City
Tulua
Country
Colombia
Facility Name
RTS Ltda Villavicencio
City
Villavicencio
Country
Colombia

12. IPD Sharing Statement

Learn more about this trial

Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

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