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

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ClinicalTrials.gov Identifier: NCT00567489
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) 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 only) 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 or disease Intervention/treatment Phase
ESRD Diabetes CAPD APD Drug: Physioneal Drug: Dianeal Drug: Extraneal Drug: Nutrineal Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial
Study Start Date : January 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Non glucose sparing
Dianeal only
Drug: Dianeal
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
Experimental: glucose sparing
PEN solutions: Nutrineal, Extraneal, and Physioneal
Drug: Physioneal
Physioneal 40 or Physioneal 35
Drug: Extraneal
7.5% Icodextrin
Drug: Nutrineal
Amino Acids 1.1%



Primary Outcome Measures :
  1. Change from the baseline value in HbA1c between the PEN group compared to the Dianeal only group [ Time Frame: 6 Month ]

Secondary Outcome Measures :
  1. Glycemic control medication usage, hypoglycemic events, metabolic control, nutritional status, and QOL. [ Time Frame: 6 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 Dianealand/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. Maltose, or isomaltose intolerance
  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. Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day 1.
  10. Receiving rosiglitazone maleate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567489


Locations
Hong Kong
Prince of Wales Hospital Chinese University of Hong Kong
Sha Tin, N.t., Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, N.t., Hong Kong
Kwong Wah Hospital
Kowloon, Hong Kong
Korea, Republic of
Kyungpook National University Hospital
Chung-Gu, Deagu, Korea, Republic of, 700-721
Daegu Fatima Hospital
Dong-gu, Deagu, Korea, Republic of, 701-600
Yeungnam University Medical Center
Nam-gu, Deagu, Korea, Republic of, 705-717
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei University of Medical Center Severance Hospital
Seoul, Korea, Republic of, 120-752
Russian Federation
Moscow Clinical Hospital # 52
Moscow, Russian Federation
Moscow Hospital n a S P Botkin
Moscow, Russian Federation
Moscow Research n a M F Vladimirsky
Moscow, Russian Federation
Moscow State Medical Institution: "Municipal Clinical Hospital #7 "
Moscow, Russian Federation
Samara Hospital n a M I Kalinin
Samara, Russian Federation
St Petersburg Mariinskaya Hospital
St Petersburg, Russian Federation
St Petersburg St Elizabeth Hospital
St Petersburg, Russian Federation
Singapore
National University Hospital
Singapore, Singapore, 119074
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Baxter Healthcare Corporation Call central contact for information

Publications:
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00567489     History of Changes
Other Study ID Numbers: 31998
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
ESRD
Diabetes
CAPD
APD

Additional relevant MeSH terms:
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions