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

NCT ID: NCT01219959

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

End Stage Renal Disease (ESRD); Diabetes; CAPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-glucose Sparing

Dianeal only

Group Type: ACTIVE_COMPARATOR

Dianeal

Intervention Type: DRUG

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose

Glucose Sparing

Dianeal, Extraneal, Nutrineal

Group Type: EXPERIMENTAL

Dianeal, Extraneal, Nutrineal

Intervention Type: DRUG

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Interventions

Dianeal

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose

Intervention Type: DRUG

Dianeal, Extraneal, Nutrineal

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nefrosalud Ltda

Armenia, , Colombia

RTS Ltda Barranquila

Barranquilla, , Colombia

RTS Ltda Soledad

Bogotá, , 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

Cúcuta, , Colombia

RTS Ltda Girardot

Girardot, , Colombia

Unidad Renal de Tolima

Ibagué, , Colombia

RTS Ltda Sucursal Medellin

Medellín, , Colombia

RTS Ltda Valle de Aburra

Medellín, , Colombia

RTS Ltda Sogamoso

Sogamoso, , Colombia

RTS Sucrusal Tulua

Tuluá, , Colombia

RTS Ltda Villavicencio

Villavicencio, , Colombia

Countries

Colombia

Other Identifiers

51067

Identifier Type: -

Identifier Source: org_study_id