Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%)ā¦ (NCT01093547) | Clinical Trial Compass
WithdrawnPhase 4
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
Colombia0Started 2010-02
Plain-language summary
Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange. The purpose of the study is to investigate if the use of Extraneal (which is a mixture of high weight glucose polymers), instead of glucose-based solutions such as Dianeal is going to lower the HOMA index in non-diabetic CAPD patients.
Who can participate
Age range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* must be over 18-years old and under 75-years old
* Peritoneal Equilibration Test (PET) result of high, high average or low average transport
* non-diabetic patient
* be in Continuous Ambulatory Peritoneal Dialysis (CAPD)
* prevalent patients that have been in peritoneal dialysis at least 30 days
* wish to participate
Exclusion Criteria:
* Have a Charlson score of \>7 and have a life expectancy of less than 12 months
* HIV positive
* present with peritonitis in the month prior to randomisation
* present with cardiovascular, metabolic or infection complications that have required hospitalisation in the month prior to the randomisation
* have active cancer
* pregnant women
* patients with known allergy to starch-based polymer
* patients who have a significant psychiatric disorder or mental disability that could interfere with the patientĀ“s ability to provide Informed Consent and comply with the protocol procedures
* women incapable of maintaining an effective and accepted contraception method