None listed
Conditions
Interventions
Investigational drug - balance solutions in Biofine, platicizer-free solution bags
Sponsors
Fresenius Medical Care Asia Pacific & Fresenius Medical Care Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of end stage renal disease - First treatment for ESRD by any dialysis modality within 90 days prior to or following enrolment - Selected to be treated by CAPD/APD- Residual GFR at enrolment >/= 5 ml/min/1.73m2 - Urine volume per day >/= 400 ml at enrolment- Written informed consent before any trial related activities- Ability to understand the nature and requirements of this trial.
Exclusion criteria
Prognosis for survival less than 12 months- Pregnancy or lactation period- History of malignancy other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix within the last 5 years- Any acute infections at the time of enrolment into the study- Any disease of the abdominal wall such as injury or surgery, burns, hernia, dermatitis in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis- Any Inflammatory bowel diseases (Crohns’ disease, ulcerative colitis or diverticulitis) in the opinion of the Investigator would preclude the patient from being able to have peritoneal dialysis- Any intra-abdominal tumours or intestinal obstruction- Any patient with active serositis- Any condition (mental or physical) that would interfere with the patient’s ability to comply with the study protocol- Known or suspected allergy to trial product or related products- Participation in any other clinical trial where an intervention is designed to moderate rate of change of residual renal function
Outcome results
None listed