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Cardiovascular MortalityIndependentNCT00710788

Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis

A study testing sevelamer phosphate-binders and Calcium Carbonate in people with Cardiovascular Mortality, run by Azienda Sanitaria ASL Avellino 2 at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cardiovascular Mortality
What is being tested?
sevelamer phosphate-binders and Calcium Carbonate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteItaly
Study dates
Jan 2007to Sep 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Nephrology Division

    Solofra, Avellino, 83100

Other trials in Italy

About this study

Official title: Interventional, Multicenter, Prospective, Randomized Trial to Slow Down the Progression of Cardiovascular Calcifications to Reduce QTd in Incident Dialysis Patients

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

Read the detailed description

The risk of developing cardiovascular diseases in patients on hemodialysis is higher than in general population. Higher levels of serum phosphate are associated with adverse cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. Given the biological importance of serum phosphorus, it is conceivable that also within the normal range values the higher serum phosphate levels may be associated with the worst outcome. Several paper have shown that vascular calcifications in dialysis patients are associated with increased relative risk of death; it has also been demonstrated in uremic patients that vascular calcifications decrease arterial elasticity. We previously observed that vascular calcification directly correlate with QT interval (QTc) as well as QT dispersion (QTd) in dialysis. Also, QT correction (obtained by the correction of phosphoremia and dyslipidemia) can ameliorate the development of arrhythmia and sudden death. Aim of this study is to evaluate the relationship between vascular calcifications and both QTd increase and mortality in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce vascular calcifications and QTd.

Being tested
sevelamer phosphate-binders, Calcium Carbonate
Keywords
QT interval, QT dispersion, arrhythmias, death, TC score
Medical subject headings
Arrhythmias, Cardiac, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sevelamer phosphate-bindersDrug

    Also called Renagel

    1600 mg/day for 2 years

  • Calcium CarbonateDrug

    Calcium carbonate 1 g/day for 2 years

Study groups in NCT00710788
Study groupRoleWhat they receive
1Experimentalsevelamer as Phosphate-binder treatment
Receives: Drug: sevelamer phosphate-binders
2Active comparatorCalcium carbonate
Receives: Drug: Calcium Carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (1)

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2010
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00710788
Sponsor's protocol ID
2008.1
Other IDs
2008.1.brd.renagel
Acronym
Independent
Status last verified
Feb 2013
First submitted
2 Jul 2008
Last updated
12 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18573137

  • 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.

    PubMed 16940716

  • 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.

    PubMed 16880182

  • 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.

    PubMed 18451682

  • 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.

    PubMed 18414441

  • 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.

    PubMed 18400812

  • 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.

    PubMed 18336094

  • 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.

    PubMed 18310864

  • 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.

    PubMed 18295060

  • 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.

    PubMed 18295050

  • 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.

    PubMed 18235525

  • 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.

    PubMed 18199805

  • 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.

    PubMed 18089452

  • 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.

    PubMed 17805238

Questions about this trial

What is this clinical trial studying?

A study testing sevelamer phosphate-binders and Calcium Carbonate in people with Cardiovascular Mortality, run by Azienda Sanitaria ASL Avellino 2 at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00710788, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.

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