The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Renal Failure	Drug: Solution B (balance PD solution) Drug: Solution A (conventional PD solution)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:

CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	30
Study Start Date:	July 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Solution B (balance PD solution) Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)	Drug: 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 Other Name: Balance
Active Comparator: Solution A (conventional PD solution) Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)	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) Other Name: CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19

Arms

Assigned Interventions

Experimental: Solution B (balance PD solution)

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

Drug: 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

Other Name: Balance

Active Comparator: Solution A (conventional PD solution)

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

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)

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753154

Locations

Poland
Centrum Dializ Fresenius Nephrocare
Gdańsk,, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland
Uniwersytecki Szpital Kliniczny nr 1
Łódź, Poland
Spain
Complejo hospitalario universitario de Albacete
Albacete, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Fundación Hospital Alcorcón
Madrid, Spain

Sponsors and Collaborators

Fresenius Medical Care Deutschland GmbH

Investigators

Principal Investigator:

Mariano Feriani, MD

Ospedale Umberto Oo, 30174 Mestre, Italy

More Information

No publications provided

Responsible Party:	Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT01753154 History of Changes
Other Study ID Numbers:	PD-NL-04-EU
Study First Received:	December 17, 2012
Last Updated:	March 19, 2013
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios Poland: Ministry of Health

Keywords provided by Fresenius Medical Care Deutschland GmbH:

Peritoneal Dialysis
Biocompatible dialysis solution
Hydration status
Residual renal function

Body composition monitor
Bioimpedance spectroscopy
Cancer antigen 125

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013