Status:
COMPLETED
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End Stage Renal Disease (ESRD)
Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Male or Female patients 18 years of age or older
- Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\]
- CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
- Diabetes Mellitus (Type 1 and 2)
- HbA1c \> 6.0% but ≤ 12.0%
- Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
- Total Kt/V ≥ 1.7
Exclusion
- Blood Urea Nitrogen (BUN) \> 95 mg/dL
- Exposure to Extraneal within 60 days of Screening
- Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77mm Hg) at Screening
- Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
- Cardiovascular event within the last 30 days
- Ongoing clinically significant congestive heart failure \[New York Heart Association (NYHA) class III or IV\]
- Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
- Receiving rosiglitazone maleate
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01219959
Start Date
October 1 2010
End Date
July 1 2011
Last Update
July 24 2025
Active Locations (16)
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1
Nefrosalud Ltda
Armenia, Colombia
2
RTS Ltda Barranquila
Barranquilla, Colombia
3
RTS Ltda Soledad
Bogotá, Colombia
4
Rts Ltda Ag H.U.S
Bucaramanga, Colombia