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

NCT00794326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-02-27

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Failure

Interventions

DRUG

Solution for Peritoneal Dialysis

Treatment with one bag per day during 6 months

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Simon Davies, Prof · University Hospital of North Staffordshire, Stoke-on-Trent, UK

  • Bengt Rippe, Prof · Lund University

  • Börje Haraldsson, Prof · Sahlgrenska University Hospital, Göteborg, Sweden

  • François Vrtovsnik, Prof · Bichat -Claude Bernard Hospital, Paris, France

  • Vedat Schwenger, Dr · Universitätsklinik University Hospital, Heidelberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Denmark
  • France
  • Germany
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794326 on ClinicalTrials.gov