Prospective, randomized, multi-center, double-blind, controlled, two-period, two-treatment, crossover, phase II trial to evaluate the safety and efficacy of PD-protec® in peritoneal dialysis in patients with chronic renal failure

INTERVENTION: 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 type: equal Concentration number: 1,36‐ Trade Name: Dipeptiven Product Name: Dipeptiven Pharmaceutical Form: Concentrate and solvent for solution for injection CAS Number: 39537‐23‐0 Other descriptive name: N(2)‐L‐ALANYL‐L‐GLUTAMINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intraperitoneal use 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 type: equal Concentration number: 2,27‐ 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 type: equal Concentration number: 3,86‐ 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 type: equal Concentration number: 1,36‐ 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 type: equal Concentration number: 2,27‐ 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 type: equal Concentration number: 3,86‐ CONDITION: End Stage Renal Disease Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: To examine if PD‐protec® provides benefits for peritoneal health by measuring CA‐125 and ex‐vivo stimulated IL‐6 release 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; 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; Timepoint(s) of evaluation of this end point: at the end of 8 weeks treatment SECONDARY OUTCOME: 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 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