Status:
WITHDRAWN
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
Lead Sponsor:
Iperboreal Pharma Srl
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized, cross-over, controlled, open label study. The aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal PD soluti...
Detailed Description
The use of a solution icodextrin, xylitol and carnitine (IXC) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (UF) through colloid osmosis, allowing a ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months
- A stable clinical condition during the two weeks immediately prior to randomization
- Blood hemoglobin concentration above 8,5 g/100ml
- Has not experienced peritonitis episodes in the last 3 months
- Treated with Extraneal for at least 1 month
- Peritoneal Equilibration Test (PET) performed in the last three months
- Has understood and signed the Informed Consent Form.
Exclusion
- History of drug or alcohol abuse in the six months prior to entering the protocol
- Acute infectious condition
- History of severe congestive heart failure and clinically significant arrhythmia
- Malignancy within the past 5 years, including lymphoproliferative disorders
- A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
- A clinically relevant under-hydration as judged by the treating physician
- History of L-Carnitine therapy or use in the month before entering the study
- Received any investigational drug in the 3 months before entering the study
- Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures
Key Trial Info
Start Date :
October 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04086212
Start Date
October 2 2019
End Date
April 1 2023
Last Update
October 1 2024
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