IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
NCT ID: NCT00567489
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
137 participants
INTERVENTIONAL
2008-01-31
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non glucose sparing
Dianeal only
Dianeal
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
glucose sparing
PEN solutions: Nutrineal, Extraneal, and Physioneal
Physioneal
Physioneal 40 or Physioneal 35
Extraneal
7.5% Icodextrin
Nutrineal
Amino Acids 1.1%
Interventions
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Physioneal
Physioneal 40 or Physioneal 35
Dianeal
Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
Extraneal
7.5% Icodextrin
Nutrineal
Amino Acids 1.1%
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Vantive Health LLC
INDUSTRY
Responsible Party
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Locations
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Prince of Wales Hospital Chinese University of Hong Kong
Shatin, N.T., Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, N.T., Hong Kong
Kwong Wah Hospital
Kowloon, , Hong Kong
Moscow Clinical Hospital # 52
Moscow, , Russia
Moscow Hospital n a S P Botkin
Moscow, , Russia
Moscow Research n a M F Vladimirsky
Moscow, , Russia
Moscow State Medical Institution: "Municipal Clinical Hospital #7 "
Moscow, , Russia
St Petersburg Mariinskaya Hospital
Saint Petersburg, , Russia
St Petersburg St Elizabeth Hospital
Saint Petersburg, , Russia
Samara Hospital n a M I Kalinin
Samara, , Russia
National University Hospital
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Daegu Fatima Hospital
Donggu, Deagu, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University of Medical Center Severance Hospital
Seoul, , South Korea
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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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.
American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S33-50. doi: 10.2337/diacare.26.2007.s33. No abstract available.
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.
Other Identifiers
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31998
Identifier Type: -
Identifier Source: org_study_id
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