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

November 18, 2008
January 10, 2014
October 2008
June 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00794326 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chronic Kidney Failure
Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
  • Experimental: PDsol 12
    Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
    Intervention: Drug: Solution for Peritoneal Dialysis
  • Active Comparator: Gambrosol trio 40
    Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
    Intervention: Drug: Solution for Peritoneal Dialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Denmark,   France,   Germany,   Sweden,   United Kingdom
 
NCT00794326
1449, EudraCT 2007-005365-35
Yes
Fresenius Medical Care Deutschland GmbH
Fresenius Medical Care Deutschland GmbH
Not Provided
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
Fresenius Medical Care Deutschland GmbH
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP