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Clinical Trial Details

Trial ID: L0818
Source ID: NCT00794326
Associated Drug: Solution For Peritoneal Dialysis
Title: Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
Acronym: PDOne
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Failure
Interventions: DRUG: Solution for Peritoneal Dialysis
Outcome Measures: Primary: 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., At the beginning and after 8 weeks of treatment | Secondary: Measurement of Residual Renal Function, At the beginning, at two and six months of treatment|Follow-up of frequency of hyponatremia, of AE and SAE, During whole period of the study|Assessment of changes in sodium removal, 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, At the beginning, at two and at six months of treatment|Measurement of 24hours peritoneal clearance, At the beginning and at 2 months of treatment|Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0, At the beginning, at two and six months of treatment|Office systolic and diastolic blood pressure measurement during follow up period, End of treatment, follow-up period
Sponsor/Collaborators: Sponsor: Fresenius Medical Care Deutschland GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 140
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2008-10
Completion Date: 2014-12
Results First Posted:
Last Update Posted: 2015-02-27
Locations: Rigshospitalet, Copenhagen, Denmark|CHU Saint-Jacques, Besançon, 25000, France|CHRU, Caen, 14033, France|Hospital of Chambéry, Chambery, France|CH Colmar, Colmar, France|Calydial Dialysis Center, Irigny, France|Bichat-Claude Bernard Hospital, Paris, France|ARPDD, Reims, 51726, France|CHRU de Strasbourg, Strasbourg, France|KfH-Nierenzentrum am Krankenhaus Oststadt, Hannover, 30659, Germany|University Hospital of Heidelberg, Heidelberg, Germany|KfH-Nierenzentrum, Köln, 51109, Germany|Nephrology center Offenburg, Offenburg, Germany|KfH-Nierenzentrum, Passau, 94032, Germany|PHV - Nephrologisches Zentrum Stuttgart, Stuttgart, Germany|KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder, Trier, 54292, Germany|Södra Älvborgsläns Hospital, Borås, Sweden|University Hospital of Sahlgrenska, Göteborg, Sweden|University Hospital of Lund, Lund, Sweden|University Hospital of Malmö, Malmö, Sweden|Skarborgs Hospital, Skövde, Sweden|Karolinska University Hospital, Stockholm, 14186, Sweden|Norra Älvsborgs Hospital, Trollhättan, Sweden|Birmingham Heartlands Hospital, Birmingham, B9 5SS, United Kingdom|Southmead Hospital, Bristol, BS10 5NB, United Kingdom|The Royal London Hospital, London, E1 1BB, United Kingdom|Royal Shrewsbury Hospital, Shrewsbury, SY3 8XQ, United Kingdom|University of North Staffordshire - Renal Medicine - Royal Infirmary, Stoke on Trent, ST47LN, United Kingdom|Wolverhampton New Cross Hospital, Wolverhampton, WV10 0QP, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00794326