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

NCT ID: NCT01753154

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solution B (balance PD solution)

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

Group Type: EXPERIMENTAL

Solution B (balance PD solution)

Intervention Type: DRUG

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

Solution A (conventional PD solution)

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

Group Type: ACTIVE_COMPARATOR

Solution A (conventional PD solution)

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

Balance; CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano Feriani, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Umberto Oo, 30174 Mestre, Italy

Locations

Centrum Dializ Fresenius Nephrocare

Gdansk, , Poland

Uniwersytecki Szpital Kliniczny nr 1

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, , Poland

Complejo hospitalario universitario de Albacete

Albacete, , Spain

Fundación Hospital Alcorcón

Madrid, , Spain

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Countries

Poland; Spain

Other Identifiers

PD-NL-04-EU

Identifier Type: -

Identifier Source: org_study_id