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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00567398 |
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Date of registration:
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04/12/2007 |
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Primary sponsor: |
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Public title:
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IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Impendia |
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Scientific title:
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Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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236 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00567398 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Canada
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New Zealand
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Contacts
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Name:
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Baxter Healthcare Corporation |
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Address:
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Telephone:
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Email:
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Affiliation:
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Call central contact for information |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. M/F patients 18 years of age or older
2. Diagnosis of ESRD (GFR = 15 mL/min)
3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or
4.25% dextrose/day, no prescribed dry time
4. DM (Type 1 and 2) on glycemic-control medication, for 90 days
5. HbA1c > 6.0% but = 12.0%
6. Blood hemoglobin = 8.0 g/dL, but = 13.0 g/dL
Exclusion Criteria:
1. Cardiovascular event within the last 90 days
2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)
3. Allergy to starch-based polymers
4. Glycogen storage disease
5. Glycogen storage disease
6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30
days
7. Mean Arterial Pressure (MAP) = 125 mm Hg, or volume depleted (MAP < 77) at Screening.
8. Serum urea > 30 mmol/L
9. Receiving rosiglitazone maleate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes
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ESRD
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Intervention(s)
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Drug: Dianeal
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Drug: Extraneal
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Drug: Nutrineal
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Drug: Physioneal
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Primary Outcome(s)
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Change from the baseline value in HbA1c between the PEN group compared to the Dianeal only group
[Time Frame: 6 months]
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Secondary Outcome(s)
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Glycemic control medication usage, hypoglycemic events, metabolic control, nutritional status, and QOL.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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