FindTrial
Sign In

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

Pilot Study to define the Feasibility of ex-vivo LPS stimulated Cytokine release for Testing Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to Dialysis Solutions in Peritoneal Dialysis (PD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004004-36-AT
Enrollment
Unknown
Registered
2012-12-03
Start date
2013-01-14
Completion date
Unknown
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal dialysis is a process of removing metabolic waste products and excess water from the patient's body, replacing the function of the diseased kidneys. Currently, despite the clear benefits of PD, long-term treatment is limited due to an inherent lack of biocompatibility of current PD fluids. The combination of standard PDFs and alanyl-glutamine-dipeptide is designed as a cytoprotective PDF that allows a significantly longer duration of the treatment

Interventions

Trade Name: Dipeptiven - concentrate for solution for injection/infusion Pharmaceutical Form: Concentrate for solution for injection/infusion CAS Number: 39537-23-0 Current Sponsor code: Medical Unive

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: The objective of this study is to evaluate the feasibility and safety of the addition of alanyl-glutamine-dipeptide to 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

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

Countries

Austria

Contacts

Public ContactChristoph Aufricht, Representatitve

Med. University of Vienna

christoph.aufricht@meduniwien.ac.at004301404002288

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026