The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
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
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
The appearance rate is defined as the sum of the amount of CA125 determined in each outflow bag (concentration of CA125 in outflow multiplied with outflow volume) divided by the real cumulative dwell time of all dwells performed on the day of the 24-hour dialysate collection.
Mariano Feriani, MD
Ospedale Umberto Oo, 30174 Mestre, Italy
Spain: Agencia Española de Medicamentos y Productos Sanitarios