Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

NCT00710788 | Completed DMC

• 2 other identifiers: 2008.12008.1.brd.renagel
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and QT dispersion in new haemodialysis patients.

Conditions

Cardiovascular Mortality

Keywords

QT interval; QT dispersion; arrhythmias; death; TC score

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• QT interval; PWV; mortality for acute myocardial infarction, cerebral vascular accident and heart failure; Non-CV mortality

  2 years

Study Arms (2)

1

EXPERIMENTAL

sevelamer as Phosphate-binder treatment

Drug: sevelamer phosphate-binders

2

ACTIVE COMPARATOR

Calcium carbonate

Drug: Calcium Carbonate

Interventions

sevelamer phosphate-binders DRUG

1600 mg/day for 2 years

Also known as: Renagel

1

Calcium Carbonate DRUG

Calcium carbonate 1 g/day for 2 years

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• incident patients on haemodialysis (CKD stage 5);
• an informed consent will be provided at the study entry.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria ASL Avellino 2: lead

Study Sites (1)

Nephrology Division

Solofra, Avellino, 83100, Italy

Location

Related Publications (19)

• 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

  BACKGROUND

• 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.

  PMID: 18573137 RESULT

• 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.

  PMID: 16940716 RESULT

• 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.

  PMID: 16880182 RESULT

• 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.

  PMID: 18451682 RESULT

• 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.

  PMID: 18414441 RESULT

• 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.

  PMID: 18400812 RESULT

• 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.

  PMID: 18336094 RESULT

• 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.

  PMID: 18310864 RESULT

• 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.

  PMID: 18295060 RESULT

• 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.

  PMID: 18295050 RESULT

• 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.

  PMID: 18235525 RESULT

• 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.

  PMID: 18199805 RESULT

• 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.

  PMID: 18089452 RESULT

• 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.

  PMID: 17805238 RESULT

• 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.

  PMID: 17728707 RESULT

• 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.

  PMID: 40576086 DERIVED

• 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.

  PMID: 25027030 DERIVED

• 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.

  PMID: 19967647 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Death

Interventions

Sevelamer; Calcium Carbonate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Biagio R Di Iorio, MD, PhD

  ASL AV/2, Avellino, Italy

  STUDY CHAIR

• Loreto Gesualdo, professor

  Nephrology Division, Medical School, University of Foggia

  PRINCIPAL INVESTIGATOR

• Filippo Aucella, MD

  ASL FG, Italy

  PRINCIPAL INVESTIGATOR

• Walter De Simone, MD

  AO MOscati, Avellino, Italy

  PRINCIPAL INVESTIGATOR

• Mario Migliorati, MD

  Dialysis, Torre del Greco, Italy

  PRINCIPAL INVESTIGATOR

• Domenico Santoro, MD

  Nephrology Division, Medical School, University of Messina, Italy

  PRINCIPAL INVESTIGATOR

• Pasquale Guastaferro, MD

  Nephrology Division, ASL AV1, Sant'Angelo de Lomnardi, Italy

  PRINCIPAL INVESTIGATOR

• Luigi Chiuchuilo, MD

  Dialysis, Avellino, Italy

  PRINCIPAL INVESTIGATOR

• Vincenzo Tedesco, MD

  Dialysis, Montella, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

IT (1)