Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis
NCT ID: NCT00710788
Last Updated: 2013-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
360 participants
INTERVENTIONAL
2007-01-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
sevelamer as Phosphate-binder treatment
sevelamer phosphate-binders
1600 mg/day for 2 years
2
Calcium carbonate
Calcium Carbonate
Calcium carbonate 1 g/day for 2 years
Interventions
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sevelamer phosphate-binders
1600 mg/day for 2 years
Calcium Carbonate
Calcium carbonate 1 g/day for 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* an informed consent will be provided at the study entry.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Azienda Sanitaria ASL Avellino 2
OTHER
Responsible Party
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Dr Biagio Di Iorio
MD, PhD
Principal Investigators
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Biagio R Di Iorio, MD, PhD
Role: STUDY_CHAIR
ASL AV/2, Avellino, Italy
Loreto Gesualdo, professor
Role: PRINCIPAL_INVESTIGATOR
Nephrology Division, Medical School, University of Foggia
Filippo Aucella, MD
Role: PRINCIPAL_INVESTIGATOR
ASL FG, Italy
Walter De Simone, MD
Role: PRINCIPAL_INVESTIGATOR
AO MOscati, Avellino, Italy
Mario Migliorati, MD
Role: PRINCIPAL_INVESTIGATOR
Dialysis, Torre del Greco, Italy
Domenico Santoro, MD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Division, Medical School, University of Messina, Italy
Pasquale Guastaferro, MD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Division, ASL AV1, Sant'Angelo de Lomnardi, Italy
Luigi Chiuchuilo, MD
Role: PRINCIPAL_INVESTIGATOR
Dialysis, Avellino, Italy
Vincenzo Tedesco, MD
Role: PRINCIPAL_INVESTIGATOR
Dialysis, Montella, Italy
Locations
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Nephrology Division
Solofra, Avellino, Italy
Countries
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References
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Di Iorio B, D'Avanzo E, Piscopo C, Cucciniello E, Bellizzi V: QT and phosphatemia: a novel sensitive marker of cardiovascolar risk for an old killer . 12th Assisi European Meeting on Cardionephrology, Cardionephrology 10, Nuova BIOS ed, 2008;23-26
Marangon N, Lindholm B, Stenvinkel P. Nonphosphate-binding effects of sevelamer--are they of clinical relevance? Semin Dial. 2008 Sep-Oct;21(5):385-9. doi: 10.1111/j.1525-139X.2008.00440.x. Epub 2008 Jun 19.
Di Iorio BR, Bortone S, Piscopo C, Grimaldi P, Cucciniello E, D'Avanzo E, Mondillo F, Cillo N, Bellizzi V. Cardiac vascular calcification and QT interval in ESRD patients: is there a link? Blood Purif. 2006;24(5-6):451-9. doi: 10.1159/000095362. Epub 2006 Aug 25.
Di Iorio BR, D'Avanzo E, Piscopo C, Grimaldi P, Cucciniello E, Cillo N, Bellizzi V. Progression of vascular calcification increases QT interval in haemodialysis patients. Nephrol Dial Transplant. 2006 Dec;21(12):3609-10. doi: 10.1093/ndt/gfl417. Epub 2006 Jul 31. No abstract available.
Cozzolino M, Galassi A, Pasho S, Fallabrino G, Gallieni M, Brancaccio D. Preventive measures and new pharmacological approaches of calcium and phosphate disorders. Contrib Nephrol. 2008;161:234-239. doi: 10.1159/000130696.
Nolan CR, McCarron DA. Lack of mortality benefit with sevelamer. Kidney Int. 2008 May;73(9):1093; author reply 1093-4. doi: 10.1038/ki.2008.46. No abstract available.
Wrong O, Harland C. Sevelamer. Nephrol Dial Transplant. 2008 Jun;23(6):2108; author reply 2101-2. doi: 10.1093/ndt/gfn162. Epub 2008 Apr 9. No abstract available.
Negri AL. [K-DOQI guidelines for calcium and phosphorus metabolism in chronic kidney disease: outcomes, compliance and new drugs for treatment]. Nefrologia. 2007;27(6):670-3. No abstract available. Spanish.
Hamida FB, Fatma LB, Barbouch S, Kaaroud H, Helal I, Hedri H, Abdallah TB, Maiz HB, Kheder A. Effect of sevelamer on mineral and lipid abnormalities in hemodialysis patients. Saudi J Kidney Dis Transpl. 2008 Mar;19(2):183-8.
St Peter WL, Liu J, Weinhandl E, Fan Q. A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) randomized trial using claims data. Am J Kidney Dis. 2008 Mar;51(3):445-54. doi: 10.1053/j.ajkd.2007.12.002.
Winkelmayer WC, Tonelli M. Phosphate binder choice in dialysis patients: a call for evidence-based rather than marketing-based clinical practice. Am J Kidney Dis. 2008 Mar;51(3):362-5. doi: 10.1053/j.ajkd.2008.01.004. No abstract available.
Mansour J, Shahapuni I, El Esper N, Fournier A. Block randomized trial evidencing lower mortality with sevelamer compared with calcium phosphate binder in incident dialysis patients. Kidney Int. 2008 Feb;73(4):510. doi: 10.1038/sj.ki.5002752. No abstract available.
Ferreira A, Frazao JM, Monier-Faugere MC, Gil C, Galvao J, Oliveira C, Baldaia J, Rodrigues I, Santos C, Ribeiro S, Hoenger RM, Duggal A, Malluche HH; Sevelamer Study Group. Effects of sevelamer hydrochloride and calcium carbonate on renal osteodystrophy in hemodialysis patients. J Am Soc Nephrol. 2008 Feb;19(2):405-12. doi: 10.1681/ASN.2006101089. Epub 2008 Jan 16.
Suki WN; Dialysis Clinical Outcomes Revisited Investigators. Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients: results of a randomized clinical trial. J Ren Nutr. 2008 Jan;18(1):91-8. doi: 10.1053/j.jrn.2007.10.019.
Russo D, Miranda I, Ruocco C, Battaglia Y, Buonanno E, Manzi S, Russo L, Scafarto A, Andreucci VE. The progression of coronary artery calcification in predialysis patients on calcium carbonate or sevelamer. Kidney Int. 2007 Nov;72(10):1255-61. doi: 10.1038/sj.ki.5002518. Epub 2007 Sep 5.
Suki WN, Zabaneh R, Cangiano JL, Reed J, Fischer D, Garrett L, Ling BN, Chasan-Taber S, Dillon MA, Blair AT, Burke SK. Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients. Kidney Int. 2007 Nov;72(9):1130-7. doi: 10.1038/sj.ki.5002466. Epub 2007 Aug 29.
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Ruggeri M, Bellasi A, Cipriani F, Molony D, Bell C, Russo D, Di Iorio B. Sevelamer is cost effective versus calcium carbonate for the first-line treatment of hyperphosphatemia in new patients to hemodialysis: a patient-level economic evaluation of the INDEPENDENT-HD study. J Nephrol. 2015 Oct;28(5):593-602. doi: 10.1007/s40620-014-0122-8. Epub 2014 Jul 16.
Di Iorio BR, Cucciniello E, Bellizzi V. Vascular calcification and QT interval in incident hemodialysis patients. J Nephrol. 2009 Nov-Dec;22(6):694-8.
Other Identifiers
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2008.1.brd.renagel
Identifier Type: -
Identifier Source: secondary_id
2008.1
Identifier Type: -
Identifier Source: org_study_id
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