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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00567398




Registration number
NCT00567398
Ethics application status
Date submitted
4/12/2007
Date registered
5/12/2007
Date last updated
3/06/2019

Titles & IDs
Public title
IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Scientific title
Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial
Secondary ID [1] 0 0
34202
Universal Trial Number (UTN)
Trial acronym
Impendia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ESRD 0 0
Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dianeal
Treatment: Drugs - Physioneal
Treatment: Drugs - Extraneal
Treatment: Drugs - Nutrineal

Active Comparator: non glucose sparing - Dianeal only

Experimental: Glucose sparing - Physioneal, Extraneal, Nutrineal


Treatment: Drugs: Dianeal
Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)

Treatment: Drugs: Physioneal
Physioneal 40 or Physioneal 35

Treatment: Drugs: Extraneal
Extraneal - 7.5% Icodextrin

Treatment: Drugs: Nutrineal
Nutrineal - 1.1% Amino Acids

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [2] 0 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.
Timepoint [2] 0 0
Baseline through Month 6 (End of Study)
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [4] 0 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.
Timepoint [4] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [5] 0 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.
Timepoint [5] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [6] 0 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.
Timepoint [6] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [7] 0 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
Timepoint [7] 0 0
Baseline and Month 6 (End of Study)
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [9] 0 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.
Timepoint [9] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [10] 0 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.
Timepoint [10] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [11] 0 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.
Timepoint [11] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [12] 0 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.
Timepoint [12] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [13] 0 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.
Timepoint [13] 0 0
Baseline, Month 6 (End of Study)
Secondary outcome [14] 0 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.
Timepoint [14] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [15] 0 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.
Timepoint [15] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [16] 0 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.
Timepoint [16] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [17] 0 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.
Timepoint [17] 0 0
Baseline, Month 3, Month 6 (End of Study)
Secondary outcome [18] 0 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.
Timepoint [18] 0 0
Baseline, Month 6 (End of Study)
Secondary outcome [19] 0 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.
Timepoint [19] 0 0
Baseline, Month 6 (End of Study)
Secondary outcome [20] 0 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.
Timepoint [20] 0 0
Baseline, Month 6 (End of Study)
Secondary outcome [21] 0 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.
Timepoint [21] 0 0
Baseline, Month 6 (End of Study)

Eligibility
Key inclusion criteria
1. M/F patients 18 years of age or older

2. Diagnosis of ESRD (GFR = 15 mL/min)

3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25%
dextrose/day, no prescribed dry time

4. DM (Type 1 and 2) on glycemic-control medication, for 90 days

5. HbA1c > 6.0% but = 12.0%

6. Blood hemoglobin = 8.0 g/dL, but = 13.0 g/dL
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cardiovascular event within the last 90 days

2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)

3. Allergy to starch-based polymers

4. Glycogen storage disease

5. Glycogen storage disease

6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30
days

7. Mean Arterial Pressure (MAP) = 125 mm Hg, or volume depleted (MAP < 77) at Screening.

8. Serum urea > 30 mmol/L

9. Receiving rosiglitazone maleate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Wolloongabba
Recruitment hospital [6] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [7] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [9] 0 0
Gold Coast Hospital - South Port
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
2170 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4102 - Wolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Adelaide
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
4215 - South Port
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
New Brunswick
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Baxter Healthcare Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal)
in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated
Peritoneal Dialysis (APD) 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 PD solutions (PEN vs
Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD 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. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs
Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be
assessed.
Trial website
https://clinicaltrials.gov/show/NCT00567398
Trial related presentations / publications
Gokal R. Taking peritoneal dialysis beyond the year 2000. Perit Dial Int. 1999;19 Suppl 3:S35-42; discussion S43.
Delarue J, Maingourd C, Couet C, Vidal S, Bagros P, Lamisse F. Effects of oral glucose on intermediary metabolism in continuous ambulatory peritoneal dialysis patients versus healthy subjects. Perit Dial Int. 1998 Sep-Oct;18(5):505-11.
Holmes CJ, Shockley TR. Strategies to reduce glucose exposure in peritoneal dialysis patients. Perit Dial Int. 2000;20 Suppl 2:S37-41. Review.
Furuya R, Odamaki M, Kumagai H, Hishida A. Beneficial effects of icodextrin on plasma level of adipocytokines in peritoneal dialysis patients. Nephrol Dial Transplant. 2006 Feb;21(2):494-8. Epub 2005 Oct 12.
Nundy S, Baron JH. The use of neutral red as a peroperative test of vagal innervation. Scand J Gastroenterol. 1975;10(8):847-50.
Martikainen T, Teppo AM, Gronhagen-Riska C, Ekstrand A. Benefit of glucose-free dialysis solutions on glucose and lipid metabolism in peritoneal dialysis patients. Blood Purif. 2005;23(4):303-10. Epub 2005 Jun 23.
Public notes

Contacts
Principal investigator
Name 0 0
Baxter Healthcare Corporation
Address 0 0
Call central contact for information
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications