Pilot Study to define the Feasibility of Cytokine Release for Testing Efficacy of the Additon of Alanyl-Glutamine-Dipeptide to Dialysis Solutions in Peritoneal Dialysis

Conditions: Peritoneal dialysis is a process of removing metabolic waste productsand excess water from the patient's body,replacing the function of the diseased kidneys.Currently, despite the clear benefits of PD, long-term treatment islimited due to an inherent lack ofbiocompatibility of current PD fluids. The combination of standard PDFsand alanyl-glutamine-dipeptide isdesigned as a cytoprotective PDF that allows a significantly longerduration of the treatment
Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

Registration Number: EUCTR2012-004004-36-AT

Lead Sponsor: Med. Univ. Wien, UK für Kinder und Jugendheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

signed informed consent
female, male aged > 19
chronic kindney failure; stable for 2 month on PD with Physioneal®
no peritonitis within 2 month of study start
negative pregnancy test for females with childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

maligne disease treated with chemotherapy or radiation
limited efficacy of PD due to anatomical abnormalities or severe intraabdominal
adhesion
clinically significant increased markers of inflammation
body weight < 50 kg
Patient under Immunsuppressiva

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate the feasibility and safety of the<br>addition of alanyl-glutamine-dipeptide to<br>dialysis solutions in Peritoneal Dialysis (PD) patients.;Secondary Objective: Efficacy on cellular level of 2 different dosis of alanyl glutamine;Primary end point(s): cytokine release for different timepoints;Timepoint(s) of evaluation of this end point: within 111 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): peritoneale cellpopulation at three different timepoints - characterised through<br>Cell Count<br>Zytospin<br>FACS<br>Protein/omics<br>RNA/ mRNA<br>Gln, Phagozytosis;Timepoint(s) of evaluation of this end point: within 111 days