Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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 solution for long dwell exchange.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iperboreal Pharma Srl
• Treatments: Dialysis Solutions; Icodextrin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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