IMPENDIA- PPEN VS DDDD Improved Metabolic Control In Diabetic CAPD Patients - Full Text View

Sponsored by:	Baxter Healthcare Corporation
Information provided by:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00567398

Purpose

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PPEN vs DDDD) 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 PD solutions (PPEN vs DDDD) 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. In a subgroup of patients, the impact of glucose-sparing PD solutions (PPEN vs DDDD) on abdominal fat and left ventricular (LV) structure and function will be assessed.

Condition	Intervention	Phase
ESRD Diabetes	Drug: Dianeal Drug: Physioneal Drug: Extraneal Drug: Nutrineal	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Amino acids, branched-chain Physioneal Icodextrin Dianeal

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PPEN VS DDDD In Diabetic CAPD Patients - The Impendia Trial

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Change from the baseline value in HbA1c between the PPEN group compared to the DDDD group [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Glycemic control medication usage, hypoglycemic events, metabolic control, nutritional status, and QOL. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	236
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dianeal: Active Comparator	Drug: Dianeal Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)
PPEN: Experimental Physioneal, Extraneal, Nutrineal	Drug: Physioneal Physioneal 40 or Physioneal 35 Drug: Extraneal Extraneal - 7.5% Icodextrin Drug: Nutrineal Nutrineal - 1.1% Amino Acids

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F patients 18 years of age or older
Diagnosis of ESRD (GFR ≤ 15 mL/min)
CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
DM (Type 1 and 2) on glycemic-control medication, for 90 days
HbA1c > 6.0% but ≤ 10.0%
Blood hemoglobin ≥ 9.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

APD patients
Cardiovascular event within the last 90 days
Ongoing clinically significant congestive heart failure (NYHA class III or IV)
Allergy to starch-based polymers
Glycogen storage disease
Glycogen storage disease
Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.
Serum urea > 30 mmol/L
Receiving rosiglitazone maleate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567398

Contacts

Contact: Center for One Baxter	800-422-9837	onebaxter@baxter.com
Contact: Baxter Healthcare Corporation

Locations

Australia
Gold Coast Hospital	Not yet recruiting
South Port, Australia, 4215
Australia, New South Wales
Royal Prince Alfred Hospital	Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Wollongong Hospital	Recruiting
Wollongong, New South Wales, Australia, 2500
Liverpool Hospital	Recruiting
Sydney, New South Wales, Australia, 2170
Westmead Hospital	Recruiting
Sydney, New South Wales, Australia, 2145
John Hunter Hospital	Recruiting
New Lambton Hts, New South Wales, Australia, 2305
Australia, Queensland
Princess Alexandra Hospital	Recruiting
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre	Recruiting
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre	Recruiting
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital	Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Canada, British Columbia
St. Paul's Hospital	Recruiting
Vancouver, British Columbia, Canada, Va6Z 2E8
Canada, Manitoba
Saint Boniface General Hospital	Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Beausejour Hospital Corporation	Recruiting
Moncton, New Brunswick, Canada, E1A1J9
Saint John Regional Hospital	Not yet recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
University Health Network, Toronto General Hospital	Not yet recruiting
Toronto, Ontario, Canada, M5G 2C4
Queen's University, Etherington Hall	Not yet recruiting
Kingston, Ontario, Canada, K7L 3N6
St. Joseph's Healthcare	Not yet recruiting
Hamilton, Ontario, Canada
Canada, Quebec
Montreal General Hospital	Not yet recruiting
Montreal, Quebec, Canada, H3G1A4
New Zealand, Auckland
Auckland Hospital	Not yet recruiting
Grafton, Auckland, New Zealand
New Zealand, Waikato
Waikato DHB	Recruiting
Hamilton, Waikato, New Zealand

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Baxter Healthcare Corporation

Call central contact for information

More Information

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.

Responsible Party:	Baxter Healthcare Corporation ( Bruce Culleton, Medical Director )
Study ID Numbers:	34202
Study First Received:	December 4, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00567398
Health Authority:	Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; New Zealand: Health Research Council

Keywords provided by Baxter Healthcare Corporation:

ESRD
Diabetes
CAPD

Study placed in the following topic categories:

Diabetes Mellitus

ClinicalTrials.gov processed this record on January 16, 2009