Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)

This study is currently recruiting participants.
Verified December 2014 by Fresenius Medical Care Deutschland GmbH
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT00794326
First received: November 18, 2008
Last updated: January 10, 2014
Last verified: December 2014
  Purpose

The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.


Condition Intervention Phase
Chronic Kidney Failure
Drug: Solution for Peritoneal Dialysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline. [ Time Frame: At the beginning and after 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of Residual Renal Function [ Time Frame: At the beginning, at two and six months of treatment ] [ Designated as safety issue: No ]
  • Follow-up of frequency of hyponatremia, of AE and SAE [ Time Frame: During whole period of the study ] [ Designated as safety issue: Yes ]
  • Assessment of changes in sodium removal [ Time Frame: At the beginning and at two months of treatment ] [ Designated as safety issue: No ]
  • Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes [ Time Frame: At the beginning, at two and at six months of treatment ] [ Designated as safety issue: No ]
  • Measurement of 24hours peritoneal clearance [ Time Frame: At the beginning and at 2 months of treatment ] [ Designated as safety issue: No ]
  • Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0 [ Time Frame: At the beginning, at two and six months of treatment ] [ Designated as safety issue: No ]
  • Office systolic and diastolic blood pressure measurement during follow up period [ Time Frame: End of treatment, follow-up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDsol 12
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
Active Comparator: Gambrosol trio 40
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months

Detailed Description:

Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.

Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.

The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.

In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.

The study is designed in three periods:

  • Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
  • Efficacy & Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
  • Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.
  Eligibility

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

Inclusion Criteria:

  • Chronic renal failure
  • Stable patients on PD treatment
  • Treatment at the study site for at least three months
  • Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
  • Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
  • Patients aged 18 years or more
  • Written consent to participate in the study (informed consent)
  • Able to use a three-compartment bag
  • Life expectancy and expected technical survival ≥ 9 months

Exclusion Criteria:

  • Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
  • Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
  • Natremia < 130 mmol/l, after two consecutive measurements
  • Chronic arrhythmia
  • Pregnancy or lactation
  • Participation in other studies during the study period which may affect the outcome of the present study
  • Peritonitis within one month prior to the study start
  • Exit site and /or tunnel infection
  • Patients unable to tolerate 2 L bag exchanges
  • Patients on non-compatible PD system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794326

Contacts
Contact: Adelheid Gauly, PhD +49-6172-609- ext 2260 adelheid.gauly@fmc-ag.com
Contact: Thomas Schulz, PhD +49-6172-609- ext 5457 thomas.schulz@fmc-ag.com

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Thomas Elung-Jensen, MD         
Principal Investigator: Thomas Elung-Jensen, MD         
Viborg Sygehus Recruiting
Viborg, Denmark, 8800
Contact: Else Randers, MD       Else.randers@viborg.rm.dk   
Principal Investigator: Else Randers, MD         
France
CHU Saint-Jacques Recruiting
Besançon, France, 25000
Contact: Cécile Courivaud, MD       ccourivaud@chu-besancon.fr   
Principal Investigator: Cécile Courivaud, MD         
CHRU Terminated
Caen, France, 14033
Hospital of Chambéry Terminated
Chambery, France
CH Colmar Recruiting
Colmar, France
Contact: Bernadette FALLER, MD       bernadette.faller@ch-colmar.rss.fr   
Principal Investigator: Bernadette FALLER, MD         
Calydial Dialysis Center Terminated
Irigny, France
Bichat-Claude Bernard Hospital Recruiting
Paris, France
Contact: François Vrtovsnik, Prof         
Principal Investigator: François Vrtovsnik, Prof         
ARPDD Recruiting
Reims, France, 51726
Contact: Sylvie Lavaud, Dr         
Contact       sylvie.lavaud@arpdd.asso.fr   
Principal Investigator: Sylvie Lavaud, Dr         
CHRU de Strasbourg Recruiting
Strasbourg, France
Contact: Francoise Heibel, MD       francoise.heibel@chru-strasbourg.fr   
Germany
KfH-Nierenzentrum Terminated
Düsseldorf, Germany, 40225
KfH-Nierenzentrum Terminated
Eberswalde, Germany, 16225
KfH-Nierenzentrum am Krankenhaus Oststadt Recruiting
Hannover, Germany, 30659
Contact: Reihard Brunkhorst, Prof.       reinhardt.brunkhorst@kfh-dialyse.de   
Principal Investigator: Reinhard Bunkhorst, Prof.         
University Hospital of Heidelberg Recruiting
Heidelberg, Germany
Contact: Vedat Schwenger, Pf         
Principal Investigator: Vedat Schwenger, Prof         
KfH-Nierenzentrum Recruiting
Köln, Germany, 51109
Contact: Michael Nebel, MD       michael.nebel@kfh-dialyse.de   
Principal Investigator: Michael Nebel, MD         
Nephrology center Offenburg Completed
Offenburg, Germany
KfH-Nierenzentrum Recruiting
Passau, Germany, 94032
Contact: Stefan Nunnenkamp, MD       stefan.nunnenkamp@kfh-dialyse.de   
Principal Investigator: Stefan Nunnenkamp, MD         
St. Elisabeth Clinic Completed
Straubing, Germany
PHV - Nephrologisches Zentrum Stuttgart Recruiting
Stuttgart, Germany
Contact: Thomas Schneider, MD         
Principal Investigator: Thomas Schneider         
KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder Recruiting
Trier, Germany, 54292
Contact: Stefan Weiner, Professor       stefan.weiner@kfh-dialyse.de   
Principal Investigator: Stefan Weiner, Prof.         
Sweden
Södra Älvborgsläns Hospital Terminated
Borås, Sweden
University Hospital of Sahlgrenska Recruiting
Göteborg, Sweden
Contact: Börje Haraldsson, Prof         
Principal Investigator: Börje Haraldsson, Prof         
University Hospital of Lund Recruiting
Lund, Sweden
Contact: Ole Simonsen, Dr         
Principal Investigator: Ole Simonsen, Dr         
University Hospital of Malmö Recruiting
Malmö, Sweden
Contact: Ann-Catherine Johansson, Dr         
Principal Investigator: Ann-Catherine Johansson, Dr         
Skarborgs Hospital Recruiting
Skövde, Sweden
Contact: Henrik Hadimeri, Dr         
Principal Investigator: Henrik Hadimeri, Dr         
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Olof Heimburger, Dr       Olof.heimburger@karolinska.se   
Principal Investigator: Olof Heimburger, MD         
Norra Älvsborgs Hospital Recruiting
Trollhättan, Sweden
Contact: Per Dahlberg, Dr         
Principal Investigator: Per Dahlberg, Dr         
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Indranil Dasgupta, MD         
Principal Investigator: Indranil Dasgupta, MD         
Southmead Hospital Recruiting
Bristol, United Kingdom, BS10 5NB
Contact: Udaya Udayaraj, MD       udaya.udayaraj@nbt.nhs.uk   
Principal Investigator: Udaya Udayaraj, MD         
Royal Free London Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Andrew Davenport, MD       andrewdavenport@nhs.net   
Principal Investigator: Andrew Davenport, MD         
The Royal London Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Stanley Fan, MD       fan.stanley@bartshealth.nhs.uk   
Principal Investigator: Stanley Fan, MD         
Royal Shrewsbury Hospital Recruiting
Shrewsbury, United Kingdom, SY3 8XQ
Contact: Ramakrishna Satish, MD       Satish.Ramakrishna@sath.nhs.uk   
Principal Investigator: Ramakrishna Satish, MD         
University of North Staffordshire - Renal Medicine - Royal Infirmary Recruiting
Stoke on Trent, United Kingdom, ST47LN
Contact: Davies Simon, Prof.       simondavies1@compuserve.com   
Principal Investigator: Davies Simon, Professor         
Wolverhampton New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Kanwajlit S Sandhu, MD       kanwaljit.sandhu@nhs.net   
Principal Investigator: Kanwaljit S Sandhu, MD         
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
Study Chair: Simon Davies, Prof University Hospital of North Staffordshire, Stoke-on-Trent, UK
Study Chair: Bengt Rippe, Prof Lund University
Study Chair: Börje Haraldsson, Prof Sahlgrenska University Hospital, Göteborg, Sweden
Study Chair: François Vrtovsnik, Prof Bichat -Claude Bernard Hospital, Paris, France
Study Chair: Vedat Schwenger, Dr Universitätsklinik University Hospital, Heidelberg, Germany
  More Information

No publications provided

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00794326     History of Changes
Other Study ID Numbers: 1449, EudraCT 2007-005365-35
Study First Received: November 18, 2008
Last Updated: January 10, 2014
Health Authority: Sweden: Medical Products Agency
France: ANSM - French Health Products Safety Agency
France: Institutional Ethical Committee
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Germany: Ethics Commission
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Fresenius Medical Care Deutschland GmbH:
Chronic Kidney Failure
Peritoneal Dialysis
Low sodium solution
Hypertension
Total Body Water

Additional relevant MeSH terms:
Hypertension
Kidney Failure, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014