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
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Tracking Information | ||||||||||||||||
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First Submitted Date ICMJE | November 18, 2008 | |||||||||||||||
First Posted Date ICMJE | November 20, 2008 | |||||||||||||||
Last Update Posted Date | February 27, 2015 | |||||||||||||||
Study Start Date ICMJE | October 2008 | |||||||||||||||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||||||||||||||
Current Primary Outcome Measures ICMJE |
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 ] | |||||||||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||||||||
Change History | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||||||||
Descriptive Information | ||||||||||||||||
Brief Title ICMJE | Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD | |||||||||||||||
Official Title ICMJE | 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 | |||||||||||||||
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. | |||||||||||||||
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:
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Study Type ICMJE | Interventional | |||||||||||||||
Study Phase ICMJE | Phase 3 | |||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Kidney Failure | |||||||||||||||
Intervention ICMJE | Drug: Solution for Peritoneal Dialysis
Treatment with one bag per day during 6 months
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||
Estimated Enrollment ICMJE |
140 | |||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||||||||
Actual Study Completion Date ICMJE | December 2014 | |||||||||||||||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries ICMJE | Denmark, France, Germany, Sweden, United Kingdom | |||||||||||||||
Removed Location Countries | Portugal | |||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number ICMJE | NCT00794326 | |||||||||||||||
Other Study ID Numbers ICMJE | 1449 EudraCT 2007-005365-35 |
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Has Data Monitoring Committee | Yes | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
Responsible Party | Fresenius Medical Care Deutschland GmbH | |||||||||||||||
Study Sponsor ICMJE | Fresenius Medical Care Deutschland GmbH | |||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||
Investigators ICMJE |
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PRS Account | Fresenius Medical Care Deutschland GmbH | |||||||||||||||
Verification Date | September 2014 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |