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

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ClinicalTrials.gov Identifier: NCT00794326
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Failure Drug: Solution for Peritoneal Dialysis Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : October 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Measurement of Residual Renal Function [ Time Frame: At the beginning, at two and six months of treatment ]
  2. Follow-up of frequency of hyponatremia, of AE and SAE [ Time Frame: During whole period of the study ]
  3. Assessment of changes in sodium removal [ Time Frame: At the beginning and at two months of treatment ]
  4. 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 ]
  5. Measurement of 24hours peritoneal clearance [ Time Frame: At the beginning and at 2 months of treatment ]
  6. 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 ]
  7. Office systolic and diastolic blood pressure measurement during follow up period [ Time Frame: End of treatment, follow-up period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794326


Locations
Show Show 29 study locations
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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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
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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00794326    
Other Study ID Numbers: 1449
EudraCT 2007-005365-35
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: September 2014
Keywords provided by Fresenius Medical Care Deutschland GmbH:
Chronic Kidney Failure
Peritoneal Dialysis
Low sodium solution
Hypertension
Total Body Water
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dialysis Solutions
Pharmaceutical Solutions