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Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients (NICOREN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01011699
First received: November 10, 2009
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.


Condition Intervention Phase
Chronic Renal Failure
Hemodialysis
Drug: nicotinamide
Drug: sevelamer
Drug: cinacalcet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • The comparison between nicotinamide and Sevelamer was primarily to demonstrate the noninferiority of nicotinamide in terms of control of the phosphatemia observed during the 4th, 5th and 6th months before to introduce Cinacalcet ®. [ Time Frame: 6th months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To demonstrate noninferiority of nicotinamide in terms of effect on dyslipidemia (evaluated by the ratio LDL / HDL cholesterol), the risk of hypercalcemia (PCa> 2.37 mmol / l) and increase of phospho-calcic product (> 3 , 79 mmol/l). [ Time Frame: 6 th months and one year ] [ Designated as safety issue: Yes ]
  • To evaluate the difference between nicotinamide and sevelamer on vascular calcification [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Evaluate the percentage of population requiring use of cinacalcet® to control PTH (75-300 pg/ml). Evaluate his benefit on phosphatemia and calcemia control. Prevent the need for surgical PTX, and evaluate the additional cost of treatment by cinacalcet [ Time Frame: 6th months ] [ Designated as safety issue: Yes ]
  • Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study [ Time Frame: 6th months and one year ] [ Designated as safety issue: Yes ]
  • Compare the cost-effectiveness ratio of these two treatments [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sevelamer

Titration phase with sevelamer (Renagel) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.

Increase of sevelamer dose up to 12 tablets, as follows:

0 morning, 2 noon, 2 evening (first week), then, 0 morning, 4 noon, 4 evening (second week), then, 2 morning, 4 noon, 4 evening (third week), then, 4 morning, 4 noon, 4 evening (fourth week).

Drug: sevelamer

Titration phase with sevelamer (Renagel) with the aim of phosphatemia control before 4 weeks of treatment, with stable dose of calcic carbonate.

Increase of sevelamer dose up to 12 tablets, as follows:

0 morning, 2 noon, 2 evening (first week), then, 0 morning, 4 noon, 4 evening (second week), then, 2 morning, 4 noon, 4 evening (third week), then, 4 morning, 4 noon, 4 evening (fourth week).

Other Names:
  • Renagel
  • Sevelamer
  • ATC class V03AE02
Drug: cinacalcet

After 6 months of treatment, patient screening on PTH level:

For patients with PTH > 300pg/ml, introduction of cinacalcet by level of 30 mg every 3 weeks, up to 180mg daily (administered during the meal and before next dialysis) Cinacalcet increase will be stopped once PTH < 250 pg/ml. Calcic carbonate dose will be increase once calcemia will be < 2.25 mmol/l. If maximum tolerated dose is not sufficient to prevent hypocalcemia < 2.10 mmol/l calcium of dialysis bath wille be increased up to 1.75 mmol/l and calcic carbonate will be decreased.

A dose adjustment is possible with nicotinamide to obtain a phosphatemia between 1.10 and 1.60 mmol/l.

Other Names:
  • Mimpara
  • Cinacalcet
  • ATC class H05BX01
Active Comparator: nicotinamide

Titration phase with nicotinamide (Nicobion) with the aim of phosphatemia control in 4 weeks of treatment, with stable dose of calcic carbonate.

Increase of nicotinamide dose up to 4 tablets, as follows:

0 morning, 1 noon, 0 evening (first week), then, 0 morning, 1 noon, 1 evening (second week), then, 1 morning, 1 noon, 1 evening (third week), then, 1 morning, 2 noon, 1 evening (fourth week).

Drug: nicotinamide

Titration phase of nicotinamide (Nicobion) with the aim of phosphatemia control in 4 weeks with stable dose of calcic carbonate;

Increase of nicotinamide dose of Nicobion 500mg (nicotinamide 500mg), up to 4 tablets daily, as follows:

0 morning, 1 noon, 0 evening (first week), then, 0 morning, 1 noon, 1 evening (second week), then, 1 morning, 1 noon, 1 evening (third week), then, 1 morning, 2 noon, 1 evening (fourth week).

Other Names:
  • Nicobion
  • nicotinamide
  • ATC class A11HA01
Drug: cinacalcet

After 6 months of treatment, patient screening on PTH level:

For patients with PTH > 300pg/ml, introduction of cinacalcet by level of 30 mg every 3 weeks, up to 180mg daily (administered during the meal and before next dialysis) Cinacalcet increase will be stopped once PTH < 250 pg/ml. Calcic carbonate dose will be increase once calcemia will be < 2.25 mmol/l. If maximum tolerated dose is not sufficient to prevent hypocalcemia < 2.10 mmol/l calcium of dialysis bath wille be increased up to 1.75 mmol/l and calcic carbonate will be decreased.

A dose adjustment is possible with nicotinamide to obtain a phosphatemia between 1.10 and 1.60 mmol/l.

Other Names:
  • Mimpara
  • Cinacalcet
  • ATC class H05BX01

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women or men over 18 years
  • Chronic hemodialysis (since more than 3 months)
  • Hyperphosphatemia controlled with only CaCO3
  • PO4 > 1,60 mmol/l, PCa < 2,37 mmol/l
  • patient able to understand and sign informed consent form

Exclusion Criteria:

  • PTH < 60 ou > 800 pg/ml (PTX)
  • Aluminium intoxication (aluminium level in blood > 0,5 µmol/l)
  • Score of aortic calcifications ≥ 20 (max 24)
  • Characterized intolerance with Renagel and/or Nicobion
  • Pregnant woman
  • Autoimmune disease
  • Patient known to have a bad drug compliance
  • Blood tests abnormality (thrombopenia <150 000, serum albumin <30g)
  • Hepatic tests abnormality
  • Transplant probably within 6 months
  • Patient who will need transplantation within 6 month
  • Patients receiving chemotherapy
  • Patients having a loss of dry weight of 3 kg in 3 months or 6 kg in 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011699

Contacts
Contact: Albert FOURNIER, Pr +33 3 22 45 58 41 Fournier.Albert@chu-amiens.fr
Contact: Ziad MASSY, Pr + 33 3 22 45 57 85 Massy.ziad@chu-amiens.fr

Locations
France
Centre Hospitalier Général Recruiting
Soissons, Aisne, France, 02009
Contact: Janette MANSOUR, Dr    + 33 3 23 75 72 77    Janette.mansour@ch-soissons.fr   
Contact: Bertin EBIKILI, Dr    + 33 3 23 75 72 77    sect.hemodialyse@ch-soissons.fr   
Sub-Investigator: Bertin EBIKILI, Dr         
Principal Investigator: Janette MANSOUR, Dr         
Sub-Investigator: Badri MATA, Dr         
Sub-Investigator: Aimé Rémy BOULA, Dr         
Centre Hospitalier Active, not recruiting
Lisieux, Calvados, France, 14100
ALURAD Recruiting
Limoges, Limousin, France, 87042
Contact: Carine ACHARD, Dr    + 33 5 55 43 17 40      
Principal Investigator: Carine ACHARD, Dr         
Centre Hospitalier Universitaire Recruiting
Reims, Marne, France, 51092
Contact: Philippe RIEU, Dr    +33 3 26 78 76 30    prieu@chu-reims.fr   
Contact: Hervé MAHEUT, Dr    + 33 3 26 78 76 30    hmaheut@chu-reims.fr   
Principal Investigator: Philippe RIEU, Dr         
Sub-Investigator: Hervé MAHEUT, Dr         
Sub-Investigator: Isabelle KAZES, Dr         
Sub-Investigator: Andréea PETRACHE, Dr         
Association Régionale Promotion Dialyse à domicile (ARPDD) Recruiting
Reims, Marne, France
Contact: Andréea PETRACHE, Dr    +33 3 26 77 67 90    andreea.petrache@arpdd.asso.fr   
Association pour le Développement de l'Hémodialyse Active, not recruiting
Hénin-Beaumont, Nord-Pas de Calais, France, 62110
CHRU Recruiting
Lille, Nord, France, 59037
Contact: François-Xavier GLOWACKI, PU PH    + 33 3 20 44 59 62    f.glowacki@chru-lille.fr   
Contact: Célia LESSORE DE SAINTE FOY, PH    + 33 3 20 44 57 25    c.lessore@chru-lille.fr   
Principal Investigator: François-Xavier GLOWACKI, PU PH         
Sub-Investigator: Célia LESSORE DE SAINTE FOY, PH         
Polyclinique de la Louvière Recruiting
Lille, Nord, France, 59000
Contact: Nasser HAMDINI, Dr    +33 3 20 15 71 31    hemodialyse@wanadoo.fr   
Principal Investigator: Nasser HAMDINI, Dr         
Hôpital Victor Provo Not yet recruiting
Roubaix, Nord, France, 59056
Contact: Hervé LE MONIES DE SAGAZAN, Dr    + 33 3 20 99 31 81    h.lemonies@wanadoo.fr   
Contact: Jean-Christophe SZELAG, Dr    + 33 3 20 99 31 81    jean-christophe.szelag@ch-roubaix.fr   
Principal Investigator: Hervé LE MONIES DE SAGAZAN, Dr         
Sub-Investigator: Jean-Chrsitophe SZELAG, Dr         
Centre Hospitalier Général Active, not recruiting
Valenciennes, Nord, France, 59322
Centre Hospitalier Général Recruiting
Beauvais, Oise, France, 60000
Contact: Guy LAMBREY, Dr    + 33 3 44 11 23 44    g.lambrey@ch-beauvais.fr   
Contact: Henry RENAUD, Dr    +33 3 44 11 23 44    h.renaud@ch-beauvais.fr   
Principal Investigator: Guy LAMBREY, Dr         
Sub-Investigator: Henry RENAUD, Dr         
Sub-Investigator: Patrick FOHRER, Dr         
Sub-Investigator: Larbi LAMRIBEN, Dr         
Clinique Saint Côme Active, not recruiting
Compiegne, Oise, France, 60200
Centre Hospitalier Général Active, not recruiting
Creil, Oise, France, 60100
Clinique du Bois Bernard Active, not recruiting
Bois Bernard, Pas de calais, France, 62320
Centre Hospitalier Recruiting
Boulogne sur mer, Pas de calais, France, 62200
Contact: Pierre BATAILLE, Dr    +33 3 21 99 30 51    p.bataille@ch-boulogne.fr   
Contact: Milad SHENOUDA, Dr    +33 3 21 99 30 51    miladsam@link.net   
Principal Investigator: Pierre BATAILLE, Dr         
Sub-Investigator: Milad SHENOUDA, Dr         
Centre Hospital-Universitaire d'Amiens Recruiting
Amiens, Picardie, France, 80054
Contact: Albert FOURNIER, PU PH    + 33 3 22 45 58 41    Fournier.Albert@chu-amiens.fr   
Contact: Ziad MASSY, PU PH    +33 3 22 45 57 85    Massy.ziad@chu-amiens.fr   
Sub-Investigator: Ziad MASSY, PU, PH         
Sub-Investigator: Najeh EL ESPER, PH         
Principal Investigator: Albert FOURNIER, PU PH         
Sub-Investigator: Gabriel CHOUKROUN, PU PH         
Clinique de l'Europe Active, not recruiting
Rouen, Seine maritime, France, 76040
Centre Hospitalier Recruiting
Cambrai, France, 59407
Contact: Guy DEGREMONT, Dr    + 33 3 27 73 73 33      
Principal Investigator: Guy DEGREMONT, Dr         
Sub-Investigator: Bernard PAINCHART, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Director: Albert FOURNIER, Pr Centre Hospitalier Universitaire, Amiens
Principal Investigator: Ziad MASSY, Pr Centre Hospitalier Universitaire, Amiens
  More Information

Publications:
Malluche M, Monier-faugère M, wang G, Frazao J, Coburn J, Baker N, McCary LC, Turner JA, Goodman WG: Cinaclacet Hcl reduces bone turn over and bone marrow fibrosa in hemodialysis patients with secondary hyperparathyroidism. ERA XLI congress. AbstractBook Lisboa:P218 (M016), 2004
Dament J,Gill M, Confer S, Jones C, Webster J: The bone kinetics of lanthanum in dialysis patient treated with lanthanum carbonate up to 45 years. J Am Soc Nephrol 15 (Abstract):271A (poster FPO 948), 2004
Malluche M, Faugère MC, Damment SJP, Webster I: No osteomalacia in dialysis patients treated with lanthanum carbonate up to 4.5 years. J Am Soc Nephrol 15 (supplt Abstract):p270A Poster F P0944,2004
De Smet R, Thermote F, Lameire N, Vanholder R: SEVELAMER hydrochloride (Renagel(r)) adsorbs the uremic compounds indoxyl sulfate, indole and p-creso.[Abstract]. J Am Soc Nephrol 15, 2004
Alsheikh-Ali A, Aboujaily HM, Stanek LJ, coll. e: Increases in HDL cholesterol are the strongest predictions of risk reduction in lipid intervention trials. Circulation 111 (suppltIII):813 Abstract 3754,2004

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01011699     History of Changes
Other Study ID Numbers: Amiens NICOREN, Eudract N°2008-004673-17
Study First Received: November 10, 2009
Last Updated: February 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
nicotinamide
sevelamer hydrochloride
phosphatemia
cinacalcet
dyslipidemia
vascular calcification
bone mass loss

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Niacin
Niacinamide
Nicotinic Acids
Sevelamer
Antimetabolites
Cardiovascular Agents
Chelating Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014