End Stage Renal Disease
Conditions
Interventions
Trade Name: Physioneal 40
Pharmaceutical Form: Solution for infusion
CAS Number: 14431-43-7
Other descriptive name: GLUCOSE MONOHYDRATE
Concentration unit: % (W/V) percent weight/volume
Concentration
Sponsors
Zytoprotec GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female patients aged = 19 2) Chronic renal failure 3) Stable on PD for at least 3 months without peritonitis 4) Prior treatment with continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for at least 3 months with the following PDF (Extraneal allowed, Nutrineal not allowed): a. Austria: Physioneal 40 5) Use of glucose based PDF (Physioneal 40) for at least 2 exchanges/day on at least five out of seven days per week 6) Patients expected to remain stable on PD for at least 6 months 7) In females, either childbearing potential terminated by surgery or 1 year post-menopausal, or negative pregnancy test and the willingness of practicing adequate contraception for the duration of the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device, or steroidal contraceptive (oral, transdermal, implanted, and injected) 8) Signed and dated written informed consent (IC) is obtained prior to any study-related procedure 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 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to AGD or Dipeptiven 2) Treatment with another IMP within 28 days prior to start of the study 3) Pregnancy (positive pregnancy test at screening), lactation 4) Presumed non-compliance with study procedures 5) Any malignant disease under therapy (radiation or chemotherapy) 6) Clinically significant inflammation, at the discretion of the investigator, or C-reactive protein (CRP) >5 mg/dL (=50 mg/L) 7) Concomitant immunosuppressive therapy 8) Active liver disease such as cirrhosis, active hepatitis or other active liver disease that, in the investigator’s opinion, would preclude patient’s participation in the study 9) Use of other PDF than specifically allowed in inclusion criteria (for example Nutrineal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine if PD-protec® provides benefits for peritoneal health by measuring CA-125 and ex-vivo stimulated IL-6 release;Secondary Objective: • To examine effects of PD-protec® on peritoneal and systemic disease mechanisms relevant in peritoneal dialysis (PD) patients • To evaluate local and systemic safety and tolerability ;Primary end point(s): • Peritoneal health - Mesothelial cell mass/status Cancer antigen 125 (CA-125) appearance rate in 4-hour peritoneal dialysis effluent (PDE) from peritoneal equilibration test (PET) - Peritoneal immunocompetence and inflammation Ex-vivo stimulated IL-6 release from cells in 1-hour PDE from PET ;Timepoint(s) of evaluation of this end point: at the end of 8 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Biomarkers of the effects of PD-protec® on disease mechanisms relevant in patients on PD and clinical endpoints;Timepoint(s) of evaluation of this end point: at the end of 8 weeks treatment | — |
Countries
Austria
Contacts
Public ContactBernhard Zinner
Zytoprotec GmbH
Outcome results
None listed