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

Fresenius Medical Care (FMC)

Status and phase: Completed; Phase 4

Conditions: Chronic Renal Failure

Treatments: Drug: Solution B (balance PD solution); Drug: Solution A (conventional PD solution)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753154

PD-NL-04-EU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Solution B (balance PD solution)

Experimental group

Description:

Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)

Treatment:

Drug: Solution B (balance PD solution)

Solution A (conventional PD solution)

Active Comparator group

Description:

Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)

Treatment:

Drug: Solution A (conventional PD solution)