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

April 29, 2016 updated by: Fresenius Medical Care Deutschland GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk,, Poland
        • Centrum Dializ Fresenius Nephrocare
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Łódź, Poland
        • Uniwersytecki Szpital Kliniczny Nr 1
  • Spain
      • Albacete, Spain
        • Complejo Hospitalario Universitario de Albacete
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
        • Fundacion Hospital Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 and CAPD 19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Investigators

  • Principal Investigator: Mariano Feriani, MD, Ospedale Umberto Oo, 30174 Mestre, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-NL-04-EU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Renal Failure

Clinical Trials on Solution B (balance PD solution)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe