Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Physioneal, Extraneal, Nutrineal (P-E-N) vs Dianeal Only Treatment in Diabetic CAPD and APD Patients – The IMPENDIA Trial. (Revised per Amendment A.) - IMPENDIA

• Conditions: End stage renal disease patients with Diabetes Type I and II on Continuous Ambulatory Peritoneal Dialysis and Automated Peritoneal Dialysis; MedDRA version: 9.1Level: LLTClassification code 10012660Term: Diabetic end stage renal disease

• Registration Number: EUCTR2007-001394-29-PT
• Lead Sponsor: BAXTER HEALTHCARE CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Revised per Amendment A:
3. Patients who have a diagnosis of ESRD (GFR = 15 mL/min). Re-test will be allowed within 14 days.
4. Patients performing CAPD or APD using only Dianeal and/or Physioneal, a daily prescription including at least 1 exchange or bag of 2.5% or 4.25% dextrose (2.27% or 3.86% glucose, respectively), for at least 30 days prior to Screening and who have no prescribed dry time.
6. Incident and prevalent patients with diagnosed diabetes (Type 1 and Type 2), as verified by the treating physician
7. Patients with an HbA1c > 6.0% but = 12.0% (to be determined at the Screening visit using regional central laboratories and measured according to the Diabetes Control and Complications Trial (DCCT)/National Glycohemoglobin Standardization Program (NGSP) standard). The HbA1c result will be reported as Pass or Fail to indicate that the HbA1c either meets or does not meet the inclusion criteria.
8. Patients who have a blood hemoglobin concentration = 8.0 g/dL, but = 13.0 g/dL (to be determined at screening visit using local lab). Re-test will be allowed within 14 days.
9. Patients with a total Kt/V = 1.7 at Screening. Re-test will be allowed within 14 days.
10. Patients who are expected to remain on CAPD or APD 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

Revised per Amendment A:
Excl.Criteria 1 is deleted.
10.Patients who are receiving or who have received oral or intravenous immunosuppressants (e.g., calcineurin inhibitors such as tacrolimus or cyclosporin, mycophenolate, azathioprine) or oral or intravenous corticosteroids within the last 90 days.
14.Patients who have active infectious conditions that require i.v. antibiotics or hospitalization, including but not limited to septicemia and pneumonia, within 90 days prior to the Screening visit, Day 1 (counted from last day of antibiotic treatment); or patients who have active infectious conditions that require oral antibiotics (without hospitalization), within 14 days (counted from last day of antibiotic treatment).
15.Patients who have ongoing clinically significant congestive heart failure (New York Heart Association [NYHA] class III or IV), as judged by the investigator.
23.Patients who have received antibiotics within 30 days of the first screening visit (counted from last day of antibiotic treatment) for the treatment of peritonitis. Note: patients who have received antibiotic infection prophylaxis (i.e., during the insertion of a PD catheter) are not excluded from enrollment.
28.Patients with a serum urea > 30 mmol/L at Screening Day 2. Re-test will be allowed within 14 days.
29.Patients who have been exposed to Extraneal, or Nutrineal within 60 days prior to Screening visit, Day 1.

Study & Design

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