Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of PPEN vs DDDD in Diabetic CAPD Patients - The IMPENDIA trial - IMPENDIA

• Conditions: End Stage renal disease in Diabetic patients in CAPD; MedDRA version: 9.1Level: LLTClassification code 10012660Term: Diabetic end stage renal disease

• Registration Number: EUCTR2007-001394-29-IT
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

Diabetic (Type 1 and 2) patients of either sex aged 18 years or older with a diagnosis of end-stage renal disease (ESRD) (GFR ≤ 15 mL/min) who have been performing CAPD for at least 30 days and using only Dianeal solutions will be enrolled in the study. Patients must be of stable clinical condition, have a daily CAPD prescription of Dianeal that includes at least one exchange of 2.5% or 4.25% dextrose (2.27% or 3.86% glucose) with no prescribed dry time, require glycemic-control with insulin and/or oral hypoglycemic agents, have HbA1c of > 6.0% but ≤ 10.0%, have a blood hemoglobin ≥ 9.0 but ≤ 13.0 g/dL, have a total Kt/V ≥ 1.7, and be expected to remain on CAPD for at least 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients in Automated Peritoneal Dialysis; pregnant or lactating women; patients with cardiovascular disorders; patients whose abdominal wall is compromised for any disease or intervention; patients with active liver diseases or active infections or past severe infections; patients with allergies or intolerance to any component of the dialysis solutions; patients with malignancies; patients who received antibiotics in the last 30 days; patients with psichiatric disorders; HIV patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified