The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
|Chronic Renal Failure||Drug: Solution B (balance PD solution) Drug: Solution A (conventional PD solution)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis|
- CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration [ Time Frame: 16 weeks ]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.
|Study Start Date:||July 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Solution B (balance PD solution)
Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)
Drug: Solution B (balance PD solution)
balance 1.5% glucose, solution for peritoneal dialysis; balance 2.3% glucose, solution for peritoneal dialysis; balance 4.25% glucose, solution for peritoneal dialysis, each with 1.25 mmol/l or 1.75 mmol/l calcium
Other Name: Balance
Active Comparator: Solution A (conventional PD solution)
Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)
Drug: Solution A (conventional PD solution)
Solutions for peritoneal dialysis: CAPD 2 (1.5% glucose, 1.75mmmol/l calcium), CAPD 3 (4.25 % glucose, 1.75mmmol/l calcium), CAPD 4 (2.3% glucose, 1.75mmmol/l calcium), CAPD 17 (1.5% glucose, 1.25mmmol/l calcium), CAPD 18 (4.25% glucose, 1.25mmmol/l calcium) and CAPD 19 (2.3% glucose, 1.25mmmol/l calcium)
Other Name: CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753154
|Centrum Dializ Fresenius Nephrocare|
|Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie|
|Uniwersytecki Szpital Kliniczny nr 1|
|Complejo hospitalario universitario de Albacete|
|Fundación Hospital Alcorcón|
|Hospital Universitario Puerta de Hierro|
|Hospital Universitario Ramón y Cajal|
|Principal Investigator:||Mariano Feriani, MD||Ospedale Umberto Oo, 30174 Mestre, Italy|