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Sponsored by: |
Gambro Lundia AB |
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Information provided by: | Gambro Lundia AB |
ClinicalTrials.gov Identifier: | NCT00794326 |
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 | Intervention | Phase |
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Chronic Kidney Failure |
Drug: Solution for Peritoneal Dialysis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 140 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PDsol 12: Experimental
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
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Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
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Gambrosol trio 40: Active Comparator
Treatment with the Gambrosol trio 40 isotonic bag (1.5%)
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Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
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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. Gambro's 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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christina Schönborg | christina.schonborg@gambro.com | |
Contact: Catherine Collier | catherine.collier@gambro.com |
France | |
Bichat-Claude Bernard Hospital | Active, not recruiting |
Paris, France | |
Calydial Dialysis Center | Not yet recruiting |
Irigny, France | |
Contact: Agnès Caillette- Beaudoin, Dr | |
Principal Investigator: Agnès Caillette- Beaudoin, Dr | |
Hospital of Chambéry | Active, not recruiting |
Chambery, France | |
Germany | |
University Hospital of Heidelberg | Not yet recruiting |
Heidelberg, Germany | |
Contact: Vedat Schwenger, PD Dr | |
Principal Investigator: Vedat Schwenger, PD Dr | |
St. Elisabeth Clinic | Not yet recruiting |
Straubing, Germany | |
Contact: Marianne Haag-Weber, Prof | |
Principal Investigator: Marianne Haag-Weber | |
Coburg Clinic | Not yet recruiting |
Coburg, Germany | |
Contact: Markus Ketteler, Prof | |
Principal Investigator: Markus Ketteler, Prof | |
Portugal | |
Hospital de Santo António | Not yet recruiting |
Porto, Portugal | |
Contact: Maria João Carvalho, Dr | |
Principal Investigator: Maria João Carvalho, Dr | |
Sweden | |
University Hospital of Sahlgrenska | Recruiting |
Göteborg, Sweden | |
Contact: Börje Haraldsson, Prof | |
Principal Investigator: Börje Haraldsson, Prof | |
University Hospital of Lund | Recruiting |
Lund, Sweden | |
Contact: Ole Simonsen, Dr | |
Principal Investigator: Ole Simonsen, Dr | |
University Hospital of Malmö | Recruiting |
Malmö, Sweden | |
Contact: Ann-Catherine Johansson, Dr | |
Principal Investigator: Ann-Catherine Johansson, Dr | |
Skarborgs Hospital | Recruiting |
Skövde, Sweden | |
Contact: Henrik Hadimeri, Dr | |
Principal Investigator: Henrik Hadimeri, Dr | |
Södra Älvborgsläns Hospital | Recruiting |
Borås, Sweden | |
Contact: Finn-David Nielsen, Dr | |
Principal Investigator: Finn-David Nielsen, Dr | |
Norra Älvsborgs Hospital | Recruiting |
Trollhättan, Sweden | |
Contact: Per Dahlberg, Dr | |
Principal Investigator: Per Dahlberg, Dr | |
United Kingdom | |
North Staffordshire Hospital | Not yet recruiting |
Stoke-on-trent, United Kingdom | |
Contact: Simon Davies, Prof | |
Principal Investigator: Simon Davies, Prof | |
Addenbrooke's Dialysis Centre | Not yet recruiting |
Cambridge, United Kingdom | |
Contact: Paul Williams, Dr | |
Principal Investigator: Paul Williams, Dr | |
St James's University Hospital | Not yet recruiting |
Leeds, United Kingdom | |
Contact: Graham Woodrow, Dr | |
Principal Investigator: Graham Woodrow, Dr | |
The Royal London Hospital | Not yet recruiting |
London, United Kingdom | |
Contact: Stanley Fan, Dr | |
Principal Investigator: Stanley Fan, Dr | |
Ipswich Hospital | Not yet recruiting |
Ipswich, United Kingdom | |
Contact: Paul Williams, Dr. | |
Principal Investigator: Paul Williams, Dr. |
Study Chair: | Simon Davies, Prof | University Hospital of North Staffordshire, Stoke-on-Trent, UK |
Study Chair: | Bengt Rippe, Prof | Lund University, Sweden |
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 |
Responsible Party: | Gambro Lundia AB ( Christina Schönborg Study Director ) |
Study ID Numbers: | 1449, EudraCT 2007-005365-35 |
Study First Received: | November 18, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00794326 |
Health Authority: | Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; Portugal: National Pharmacy and Medicines Institute; Portugal: Ethics Committee for Clinical Research |
Chronic Kidney Failure Peritoneal Dialysis Low sodium solution Hypertension Total Body Water |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Hypertension Kidney Failure |