Multi-center, double-blinded, phase II trial to evaluate the safety and efficacy of PD-protec® in patients on Peritoneal Dialysis.

Phase 1

• Conditions: End Stage Renal Disease; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2013-000400-42-AT
• Lead Sponsor: Zytoprotec GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified