Clinical trial NCT01753154: The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
Official title: The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: Peritoneal Dialysis
Biocompatible dialysis solution
Hydration status
Residual renal function
Body composition monitor
Bioimpedance spectroscopy
Cancer antigen 125
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 physician
* 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 study

Primary outcomes:
measure: CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk,
country: Poland
facility: Centrum Dializ Fresenius Nephrocare
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1
city: Albacete
country: Spain
facility: Complejo hospitalario universitario de Albacete
city: Madrid
country: Spain
facility: Fundación Hospital Alcorcón
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Ospedale Umberto Oo, 30174 Mestre, Italy
name: Mariano Feriani, MD
role: PRINCIPAL_INVESTIGATOR
References: