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

February 26, 2015 updated by: Fresenius Medical Care Deutschland GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • France
      • Besançon, France, 25000
        • CHU Saint-Jacques
      • Caen, France, 14033
        • CHRU
      • Chambery, France
        • Hospital of Chambéry
      • Colmar, France
        • CH Colmar
      • Irigny, France
        • Calydial Dialysis Center
      • Paris, France
        • Bichat-Claude Bernard Hospital
      • Reims, France, 51726
        • ARPDD
      • Strasbourg, France
        • CHRU de Strasbourg
  • Germany
      • Hannover, Germany, 30659
        • KfH-Nierenzentrum am Krankenhaus Oststadt
      • Heidelberg, Germany
        • University Hospital of Heidelberg
      • Köln, Germany, 51109
        • KfH-Nierenzentrum
      • Offenburg, Germany
        • Nephrology center Offenburg
      • Passau, Germany, 94032
        • KfH-Nierenzentrum
      • Stuttgart, Germany
        • PHV - Nephrologisches Zentrum Stuttgart
      • Trier, Germany, 54292
        • KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
  • Sweden
      • Borås, Sweden
        • Södra Älvborgsläns Hospital
      • Göteborg, Sweden
        • University Hospital of Sahlgrenska
      • Lund, Sweden
        • University Hospital of Lund
      • Malmö, Sweden
        • University Hospital of Malmö
      • Skövde, Sweden
        • Skarborgs Hospital
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital
      • Trollhättan, Sweden
        • Norra Älvsborgs Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Stoke on Trent, United Kingdom, ST47LN
        • University of North Staffordshire - Renal Medicine - Royal Infirmary
      • Wolverhampton, United Kingdom, WV10 0QP
        • Wolverhampton New Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At the beginning and after 8 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1449 (Other Identifier: CSL Behring)
  • EudraCT 2007-005365-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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