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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:
NCT00567489
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 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 Intervention Phase
ESRD
Diabetes
CAPD
APD
Drug: Physioneal
Drug: Dianeal
Drug: Extraneal
Drug: Nutrineal
Phase 4

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 To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only 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 Month ] [ 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: January 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
Dianeal
Drug: Dianeal
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
Experimental: PEN
Nutrineal, Extraneal, and Physioneal
Drug: Physioneal
Physioneal 40 or Physioneal 35
Drug: Extraneal
7.5% Icodextrin
Drug: Nutrineal
Amino Acids 1.1%

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Research n a M F Vladimirsky
Moscow, Russian Federation
Moscow Hospital n a S P Botkin
Moscow, Russian Federation
Moscow Clinical Hospital # 52
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
  More Information

Publications:
Responsible Party: Bruce Culleton, Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00567489     History of Changes
Other Study ID Numbers: 31998
Study First Received: December 4, 2007
Last Updated: August 1, 2011
Health Authority: Korea: Food and Drug Administration
Singapore: Health Sciences Authority
Taiwan: Institutional Review Board
Hong Kong: Department of Health
European Union: European Medicines Agency
Austria: Ethikkommission
France: Ministry of Health
France: Institutional Ethical Committee
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Italy: National Bioethics Committee
Poland: Ministry of Health
Portugal: Ethics Committee for Clinical Research
Spain: Spanish Agency of Medicines
Spain: Ethics Committee
Czech Republic: Ethics Committee
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application

Keywords provided by Baxter Healthcare Corporation:
ESRD
Diabetes
CAPD
APD

ClinicalTrials.gov processed this record on November 23, 2014