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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Solution B (balance PD solution)
Solution A (conventional PD solution)
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Peritoneal Dialysis, Biocompatible dialysis solution, Hydration status, Residual renal function, Body composition monitor, Bioimpedance spectroscopy, Cancer antigen 125

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centrum Dializ Fresenius Nephrocare
  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Uniwersytecki Szpital Kliniczny nr 1
  • Complejo hospitalario universitario de Albacete
  • Fundación Hospital Alcorcón
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Solution B (balance PD solution)

Solution A (conventional PD solution)

Arm Description

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

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

Outcomes

Primary Outcome Measures

CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2012
Last Updated
April 29, 2016
Sponsor
Fresenius Medical Care Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01753154
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Peritoneal Dialysis, Biocompatible dialysis solution, Hydration status, Residual renal function, Body composition monitor, Bioimpedance spectroscopy, Cancer antigen 125

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solution B (balance PD solution)
Arm Type
Experimental
Arm Description
Treatment 8 weeks with solution B (balance PD solution), next 8 weeks with solution A (conventional PD solution)
Arm Title
Solution A (conventional PD solution)
Arm Type
Active Comparator
Arm Description
Treatment 8 weeks with solution A (conventional PD solution), next 8 weeks with solution B (balance PD solution)
Intervention Type
Drug
Intervention Name(s)
Solution B (balance PD solution)
Other Intervention Name(s)
Balance
Intervention Description
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
Intervention Name(s)
Solution A (conventional PD solution)
Other Intervention Name(s)
CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19
Intervention Description
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)
Primary Outcome Measure Information:
Title
CA 125 (cancer antigen 125) appearance rate in the 24 hours effluent and estimated hydration
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Feriani, MD
Organizational Affiliation
Ospedale Umberto Oo, 30174 Mestre, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Dializ Fresenius Nephrocare
City
Gdańsk,
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
City
Lublin
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1
City
Łódź
Country
Poland
Facility Name
Complejo hospitalario universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Fundación Hospital Alcorcón
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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