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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sex
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
43
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/study/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.
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. doi: 10.1093/ndt/gfi197. 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. doi: 10.1159/000086553. 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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00567398