NCT00567489

IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients

Multi-Center, Prospective, Randomized Trial To Demonstrate Improved Metabolic Control of PEN VS Dianeal Only in Diabetic CAPD and APD Patients - The Impendia Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)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 PD solutions (PEN vs Dianeal only) in diabetic (Type 1 and Type 2) CAPD and APD 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. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.

Detailed description

The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.

Conditions

• ESRD
• Diabetes
• CAPD
• APD

Interventions

Type	Name	Description
DRUG	Physioneal	Physioneal 40 or Physioneal 35
DRUG	Dianeal	Dianeal 1.5% Dextrose (1.30% glucose), 2.5% Dextrose (2.27% glucose), 4.5% Dextrose (3.86% glucose)
DRUG	Extraneal	7.5% Icodextrin
DRUG	Nutrineal	Amino Acids 1.1%

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-12-05
• Last updated: 2025-07-22
• Results posted: 2019-06-03

Locations

19 sites across 5 countries: Hong Kong, Russia, Singapore, South Korea, Taiwan