E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
|
E.1.1.1 | Medical condition in easily understood language |
The combination of standard peritoneal dialysis fluid and alanylglutamine-
dipeptide is designed as a cytoprotective PDF that allows a
significantly longer duration of the treatment. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Cell Physiological Phenomena [G04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Zu welchem Zeitpunkt des gesammelten Dialysats kann der Outcome Parameter „ex-vivo LPS stimulierten Zytokin Freisetzung aus peritonealen Leukozyten“ in über 80% der Patienten aussagekräftige Daten bringen? (Machbarkeit) |
|
E.2.2 | Secondary objectives of the trial |
Efficacy on cellular level of 2 different dosis of alanyl glutamine |
Vergleich mit vs. ohne Zugabe von Dipeptiven® in zwei Dosierungen (8
mmol und 16 mmol) zu Physioneal® hinsichtlich:
LPS stimulierte Zytokin Freisetzung, Cell count, Zytospin, FACS , Cell
culture, Protein/omics, RNA/mRNA, Gln, Phagozytose, CA125, AOPPs,
GSH/GSSG ratio und Verträglichkeit . |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
An Open Label, Randomized, Two-Period Crossover Study to Evaluate the
Safety and Efficacy of the Addition of Alanyl-Glutamine-Dipeptide to
Dialy-sis Solution in Peritoneal Dialysis (PD)
objective: Primary Objective
To evaluate treatment safety and efficacy of Alanyl-Glutamine-Dipeptide
as addition to dialysis solution in PD. |
Eine offene, randomisierte, zwei Phasen, cross-over Studie zur
Evaluierung der Sicherheit und Wirksamkeit der zusätzlichen Gabe von
Alanyl-Glutamin-Dipeptid zur Dialyse-Lösung bei Peritoneal-Dialyse.
Ziel: Die Anwendung von Alanyl-Glutamin-Dipeptid in Peritoneal-Dialyse-
Lösungen , Wirkung auf Expression der Hitze-Schock-Proteine |
|
E.3 | Principal 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 |
Unterzeichnete Patienteninformation/Einverständniserklärung vor Beginn der studienspezifischen Untersuchungen
Frauen und Männer > 19
chronisches Nierenversagen, 2 Monate stabile PD mit Physioneal®
keine Peritionitis in den letzten zwei Monaten
keine schwerwiegenden Begleiterkrankungen
Negativer Schwangerschaftstest und ausreichende Verhütung bei Frauen im gebärfähigen Alter |
|
E.4 | Principal 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 |
Bekannte Überempfindlichkeit auf das Prüfpräparat
Behandlung mit einem anderen Prüfpräparat während eines Monats vor Studienbeginn
Maligne Erkrankung mit laufender Chemo- oder Strahlentherapie
Schwangerschaft und Stillperiode
Begrenzte Effektivität der PD auf Grund anatomischer Anomalien oder schwere intraabdomineller Verwachsungen
CRP>5mg/dl
Körpergewicht < 50 kg
laufende Immunsuppressive Therapie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
cytokine release for different timepoints |
ex-vivo LPS (Lipopolysaccharid) stimulierte Zytokin Freisetzung aus
peritonealen Leukozyten zu verschiedenen Zeitpunkten jeder
Behandlungssequenz (nach 6-12h Dialysat Verweildauer(ZP0), nach 60
und 240 Minuten)
Sicherheit |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
within 111 days |
innerhalb von 111 Tagen |
|
E.5.2 | Secondary end point(s) |
peritoneale cellpopulation at three different timepoints - characterised through
Cell Count
Zytospin
FACS
Protein/omics
RNA/ mRNA
Gln, Phagozytosis |
Vergleich mit vs. ohne Zugabe von Dipeptiven® in zwei Dosierungen (8mmol und 16mmol) zu Physioneal® hinisichtlich:
LPS stimulierte Zytokin Freisetzung, Cell count, Zytospin, FACS, Cell culture, Protein/omics, RNA/mRNA, Gln, Phagozytosis, CA 125, AOPPs, GSH/GSSG ratio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
within 111 days |
innerhalb 111 Tage |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
PDF without Alanyl-Glutamine-Dipeptide |
|
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |