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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00710788 |
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Date of registration:
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02/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis
Independent |
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Scientific title:
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Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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360 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00710788 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Pasquale Guastaferro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nephrology Division, ASL AV1, Sant'Angelo de Lomnardi, Italy |
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Name:
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Walter De Simone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AO MOscati, Avellino, Italy |
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Name:
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Biagio R Di Iorio, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ASL AV/2, Avellino, Italy |
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Name:
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Vincenzo Tedesco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dialysis, Montella, Italy |
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Name:
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Domenico Santoro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nephrology Division, Medical School, University of Messina, Italy |
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Name:
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Loreto Gesualdo, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nephrology Division, Medical School, University of Foggia |
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Name:
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Filippo Aucella, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ASL FG, Italy |
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Name:
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Luigi Chiuchuilo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dialysis, Avellino, Italy |
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Name:
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Mario Migliorati, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dialysis, Torre del Greco, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- incident patients on haemodialysis (CKD stage 5);
- an informed consent will be provided at the study entry.
Exclusion Criteria:
- congenital prolongation of QT segment syndrome;
- QTc >440 ms; increased QTd;
- bradycardia <50 bpm;
- sintomatic arrhythmia or any other significant heart problems;
- electrolyte unbalances (especially hypokalemia, hypomagnesemia, hypocalcemia);
- abnormal liver function tests;
- hypothyroidism.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Mortality
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Intervention(s)
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Drug: sevelamer phosphate-binders
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Drug: Calcium Carbonate
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Primary Outcome(s)
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death due to cardiac arrhythmias or as sudden cardiac death defined as any deaths coded as "cardiac arrest, cause unknown" or "cardiac arrhythmia" without any exclusions
[Time Frame: 2 years]
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Secondary Outcome(s)
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QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality
[Time Frame: 2 years]
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Secondary ID(s)
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2008.1
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2008.1.brd.renagel
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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