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The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

Phase 4
18 Years
Open (Enrolling)
Chronic Renal Failure

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Trial Information

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
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

Inclusion Criteria:

- APD patient ≥ 18 years

- Prevalent patient with at least 3 months experience on APD prior to inclusion

- Patient is trained on and being treated with the sleep•safe APD cycler

- Patient treated on APD exclusively with registered conventional PD solutions CAPD 2,
CAPD 3, CAPD 4, CAPD 17, CAPD 18 or CAPD 19 for at least 8 weeks prior to inclusion

- Patient is on stable diuretic treatment e.g no change in diuretic treatment within
the last 30 days prior to inclusion

- Informed consent signed and dated by study patient and investigator/authorised

- Ability to understand the nature and requirements of the study

Exclusion Criteria:

- Peritonitis treatment £ 4 weeks preceding inclusion

- APD patients treated with IPD modality (intermittent peritoneal dialysis)

- Malignant disease without remission

- Patients with artificial joints, amputations, stents, or pacemaker

- Patients with congestive heart failure or coronary artery disease NYHA (New York
Heart Association) III and higher

- Active HBV (hepatitis B virus)or HCV(hepatitis C virus)infection- HIV positive

- Participation in an interventional clinical study during the preceding 30 days

- Any condition which could interfere with the patient's ability to comply with the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration

Outcome Description:

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.

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Mariano Feriani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ospedale Umberto Oo, 30174 Mestre, Italy


Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:




Start Date:

July 2011

Completion Date:

September 2013

Related Keywords:

  • Chronic Renal Failure
  • Peritoneal Dialysis
  • Biocompatible dialysis solution
  • Hydration status
  • Residual renal function
  • Body composition monitor
  • Bioimpedance spectroscopy
  • Cancer antigen 125
  • Kidney Failure, Chronic
  • Renal Insufficiency