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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01219959
First received: October 8, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
End Stage Renal Disease (ESRD)
Diabetes
CAPD
Drug: Dianeal
Drug: Dianeal, Extraneal, Nutrineal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

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 Dianeal, Extraneal, Nutrineal (D-E-N) group compared to the Dianeal only group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycemic control medication usage [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hypoglycemic events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Metabolic control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Nutritional status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dianeal Drug: Dianeal
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose
Experimental: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01219959

Locations
Colombia
Nefrosalud Ltda
Armenia, Colombia
RTS Ltda Barranquila
Barranquila, Colombia
RTS Ltda Soledad
Bogota, Colombia
Rts Ltda Ag H.U.S
Bucaramanga, Colombia
RTS Ltda STR del Valle
Cali, Colombia
RTS Ltda Versalles
Cali, Colombia
RTS Ltda H.U.V
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
Investigators
Study Director: Call central contact for information Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Bruce Culleton, Medical Director, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01219959     History of Changes
Other Study ID Numbers: 51067
Study First Received: October 8, 2010
Last Updated: August 4, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Baxter Healthcare Corporation:
ESRD
Diabetes
CAPD

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Kidney Failure, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014