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

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.

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centrum Dializ Fresenius Nephrocare, Gdansk, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solution B (balance PD solution)

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

Other names: Balance

Solution A (conventional PD solution)

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)

Other names: CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Dec 20, 2012
Registry last updated: May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed