Chronic Renal Failure Clinical Trial
Official title:
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.
Equivalence of the investigational PD solution balance regarding fluid status compared to
the conventional PD solution.
Effects of balance on inflammation and systemic advanced glycation end products formation.
Effects of balance on peritoneal and total urea clearance, on peritoneal and total
creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels.
Safety of the investigational PD solution balance and the conventional PD solution as a
control drug.
The mesothelial cell mass assessed by Cancer Antigen 125 is affected by the use of the type
of PD solution in APD patients using sleep•safe. Treating patients with the PD solution
balance leads to not more than 1 litre difference in hydration in comparison to the
conventional PD solution which is considered as clinically not relevant regarding blood
pressure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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