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Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
This study is currently recruiting participants.
Verified by Gambro Lundia AB, November 2008
Sponsored by: Gambro Lundia AB
Information provided by: Gambro Lundia AB
ClinicalTrials.gov Identifier: NCT00794326
  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 III

MedlinePlus related topics: Dietary Sodium Drinking Water High Blood Pressure Kidney Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Gambro Lundia AB:

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: August 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PDsol 12: Experimental
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
Gambrosol trio 40: Active Comparator
Treatment with the 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. Gambro's 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 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)
  • Symptomatic or asymptomatic orthostatic hypotension (defined as fall in Systolic OBP of at least 20mmHg systolic after standing for at least 1 minute)
  • Natremia < 130 mmol/l, after two consecutive measurements
  • Urine volume > 1500 ml/24 h
  • 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 (Fresenius),
  • Hernia
  • Persons with any implantable electric device (pace-maker…)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794326

Contacts
Contact: Christina Schönborg christina.schonborg@gambro.com
Contact: Catherine Collier catherine.collier@gambro.com

Locations
France
Bichat-Claude Bernard Hospital Active, not recruiting
Paris, France
Calydial Dialysis Center Not yet recruiting
Irigny, France
Contact: Agnès Caillette- Beaudoin, Dr            
Principal Investigator: Agnès Caillette- Beaudoin, Dr            
Hospital of Chambéry Active, not recruiting
Chambery, France
Germany
University Hospital of Heidelberg Not yet recruiting
Heidelberg, Germany
Contact: Vedat Schwenger, PD Dr            
Principal Investigator: Vedat Schwenger, PD Dr            
St. Elisabeth Clinic Not yet recruiting
Straubing, Germany
Contact: Marianne Haag-Weber, Prof            
Principal Investigator: Marianne Haag-Weber            
Coburg Clinic Not yet recruiting
Coburg, Germany
Contact: Markus Ketteler, Prof            
Principal Investigator: Markus Ketteler, Prof            
Portugal
Hospital de Santo António Not yet recruiting
Porto, Portugal
Contact: Maria João Carvalho, Dr            
Principal Investigator: Maria João Carvalho, Dr            
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            
Södra Älvborgsläns Hospital Recruiting
Borås, Sweden
Contact: Finn-David Nielsen, Dr            
Principal Investigator: Finn-David Nielsen, Dr            
Norra Älvsborgs Hospital Recruiting
Trollhättan, Sweden
Contact: Per Dahlberg, Dr            
Principal Investigator: Per Dahlberg, Dr            
United Kingdom
North Staffordshire Hospital Not yet recruiting
Stoke-on-trent, United Kingdom
Contact: Simon Davies, Prof            
Principal Investigator: Simon Davies, Prof            
Addenbrooke's Dialysis Centre Not yet recruiting
Cambridge, United Kingdom
Contact: Paul Williams, Dr            
Principal Investigator: Paul Williams, Dr            
St James's University Hospital Not yet recruiting
Leeds, United Kingdom
Contact: Graham Woodrow, Dr            
Principal Investigator: Graham Woodrow, Dr            
The Royal London Hospital Not yet recruiting
London, United Kingdom
Contact: Stanley Fan, Dr            
Principal Investigator: Stanley Fan, Dr            
Ipswich Hospital Not yet recruiting
Ipswich, United Kingdom
Contact: Paul Williams, Dr.            
Principal Investigator: Paul Williams, Dr.            
Sponsors and Collaborators
Gambro Lundia AB
Investigators
Study Chair: Simon Davies, Prof University Hospital of North Staffordshire, Stoke-on-Trent, UK
Study Chair: Bengt Rippe, Prof Lund University, Sweden
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

Responsible Party: Gambro Lundia AB ( Christina Schönborg Study Director )
Study ID Numbers: 1449, EudraCT 2007-005365-35
Study First Received: November 18, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00794326  
Health Authority: Sweden: Medical Products Agency;   France: Afssaps - French Health Products Safety Agency;   France: Institutional Ethical Committee;   Germany: Federal Institute for Drugs and Medical Devices;   Germany: Ethics Commission;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: Research Ethics Committee;   Portugal: National Pharmacy and Medicines Institute;   Portugal: Ethics Committee for Clinical Research

Keywords provided by Gambro Lundia AB:
Chronic Kidney Failure
Peritoneal Dialysis
Low sodium solution
Hypertension
Total Body Water

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Hypertension
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009