Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients (EDEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219959
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:

Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) 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 Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Diabetes CAPD Drug: Dianeal Drug: Dianeal, Extraneal, Nutrineal Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 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 Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients
Study Start Date : October 2010
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, 2.5% dextrose, 4.25% dextrose
Experimental: Glucose Sparing
Dianeal, Extraneal, Nutrineal
Drug: Dianeal, Extraneal, Nutrineal
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Primary Outcome Measures :
  1. Change from the baseline value in HbA1c between the Dianeal, Extraneal, Nutrineal (D-E-N) group compared to the Dianeal only group. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Glycemic control medication usage [ Time Frame: 6 months ]
  2. Hypoglycemic events [ Time Frame: 6 months ]
  3. Metabolic control [ Time Frame: 6 months ]
  4. Nutritional status [ Time Frame: 6 months ]
  5. Quality of Life [ 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

Inclusion Criteria:

  1. Male or Female patients 18 years of age or older
  2. Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min]
  3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
  4. Diabetes Mellitus (Type 1 and 2)
  5. HbA1c > 6.0% but ≤ 12.0%
  6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
  7. Total Kt/V ≥ 1.7

Exclusion Criteria:

  1. Blood Urea Nitrogen (BUN) > 95 mg/dL
  2. Exposure to Extraneal within 60 days of Screening
  3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at Screening
  4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
  5. Cardiovascular event within the last 30 days
  6. Ongoing clinically significant congestive heart failure [New York Heart Association (NYHA) class III or IV]
  7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
  8. 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 identifier (NCT number): NCT01219959

Nefrosalud Ltda
Armenia, Colombia
RTS Ltda Barranquila
Barranquila, Colombia
RTS Ltda Soledad
Bogota, Colombia
Rts Ltda Ag H.U.S
Bucaramanga, Colombia
RTS Ltda H.U.V
Cali, Colombia
RTS Ltda STR del Valle
Cali, Colombia
RTS Ltda Versalles
Cali, Colombia
Renal Therapy Services (RTS) Ltda Cartagena
Cartagena, Colombia
RTS Ltda Cucuta
Cucuta, Colombia
RTS Ltda Girardot
Girardot, Colombia
Unidad Renal de Tolima
Ibague, Colombia
RTS Ltda Sucursal Medellin
Medellin, Colombia
RTS Ltda Valle de Aburra
Medellin, Colombia
RTS Ltda Sogamoso
Sogamoso, Colombia
RTS Sucrusal Tulua
Tulua, Colombia
RTS Ltda Villavicencio
Villavicencio, Colombia
Sponsors and Collaborators
Baxter Healthcare Corporation
Study Director: Call central contact for information Baxter Healthcare Corporation

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01219959     History of Changes
Other Study ID Numbers: 51067
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dialysis Solutions
Pharmaceutical Solutions