A Study to Evaluate the Efficacy and Safety of Extraneal Physiological pH Compared with Current Extraneal in Patients Receiving Continuous Ambulatory Peritoneal Dialysis (CAPD).

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Patients who have given written informed consent after the nature of the study has been explained.
2. Patients who are at least 18 years of age.
3. Patients who have been treated with CAPD with Physioneal 40 or Dianeal PD4 and current Extraneal for at least 60 days before the baseline visit (week –2).

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit (week –4). Peritonitis being defined as 2 out of 3 of the following criteria:
a) Cloudy peritoneal effluent with peritoneal white blood cell (WBC) count > 100 cells/mm3 due predominately to neutrophils (>50%), (= 1L dialysate after = 2h dwell time).
b) Signs and symptoms of peritoneal inflammation (e.g., abdominal pain).
c) Demonstration of microorganism or yeast in the peritoneal effluent by culture or Gram’s stain.
2. Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit (week –4).
3. Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection.
4. Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit (week –2).
5. Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green method).
6. Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
7. Patients who have received an investigational product within 30 days preceding the screening visit.
8. Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
9. Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.
10. Patients who routinely add sodium bicarbonate to the dialysis bags or uses oral sodium bicarbonate.
11. Patients who routinely use Nutrineal (1.1% amino acid based solution) and cannot have this omitted from his/her regimen for the 10 week study period.
12. Patients who are allergic to starch-based polymers.
13. Patients who have glycogen storage disease.
14. Patients who have had abdominal surgery within 30 days preceding the screening visit (V0).
15. Patients who have had abdominal fistulae, tumours, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavity within 30 days preceding the screening visit (V0).
16. Patients who have maltose or isomaltose intolerance.
17. Patients who have other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Ultrafiltration for the long dwell determined by weighing the overnight dialysis bags for seven days before the 2-weekly clinic visits and calculating the mean of the measurements;<br> Main Objective: The primary objective of this study is to demonstrate the non-inferiority of Extraneal Physiological pH compared to current Extraneal with regard to long dwell ultrafiltration<br> ;<br> Secondary Objective: The secondary objectives of this study are to demonstrate the equivalence of Extraneal Physiological pH to current Extraneal with regard to acid-base status and the non-inferiority of Extraneal Physiological pH compared to current Extraneal with regard to long dwell peritoneal creatinine clearance<br>

Secondary Outcome Measures

Name	Time	Method

Related Trials