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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01753154
First received: December 17, 2012
Last updated: June 4, 2014
Last verified: June 2014
  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:


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.


Enrollment: 25
Study Start Date: July 2011
Study Completion Date: December 2013
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 4, 2014
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:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014