IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients - Full Text View

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:

MedlinePlus related topics: Diabetes

Drug Information available for: Dianeal

U.S. FDA Resources

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:

M/F patients 18 years of age or older
Diagnosis of ESRD (GFR ≤ 15 mL/min)
CAPD or APD using only Dianealand/or Physioneal, 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 ≤ 12.0%
Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

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
Maltose, or isomaltose intolerance
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
Exposure to Extraneal or Nutrineal within the last 60 days prior to Screening visit, Day 1.
Receiving rosiglitazone maleate

Contacts and Locations

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 Clinical Hospital # 52
Moscow, Russian Federation
Moscow State Medical Institution: "Municipal Clinical Hospital #7 "
Moscow, Russian Federation
Moscow Hospital n a S P Botkin
Moscow, Russian Federation
Moscow Research n a M F Vladimirsky
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:

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.

American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2003 Jan;26 Suppl 1:S33-50. No abstract available. Erratum in: Diabetes Care. 2003 Mar;26(3):972.

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:	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

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 May 16, 2013

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