IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients (Impendia)

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00567398
First received: December 4, 2007
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
ESRD
Diabetes
Drug: Dianeal
Drug: Physioneal
Drug: Extraneal
Drug: Nutrineal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Change from the baseline value in HbA1c between the PEN group compared to the Dianeal only 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
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dianeal Drug: Dianeal
Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)
Experimental: PEN
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:

  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

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

Locations
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Australia
Gold Coast Hospital
South Port, Australia, 4215
Canada, Manitoba
Saint Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Beausejour Hospital Corporation
Moncton, New Brunswick, Canada, E1A1J9
Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Royal Victoria Hospital
Montreal, Quebec, Canada
New Zealand
Auckland Hospital
Grafton, Auckland, New Zealand
Waikato DHB
Hamilton, Waikato, New Zealand
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter Healthcare Corporation Call central contact for information
  More Information

Publications:
Responsible Party: Bruce Culleton, Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00567398     History of Changes
Other Study ID Numbers: 34202
Study First Received: December 4, 2007
Last Updated: August 1, 2011
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
APD

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014