Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients (NICOREN)
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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 |
- 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 ]
- 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:
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:
|
|
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:
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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
| 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 | |
| Study Director: | Albert FOURNIER, Pr | Centre Hospitalier Universitaire, Amiens |
| Principal Investigator: | Ziad MASSY, Pr | Centre Hospitalier Universitaire, Amiens |
More Information
Publications:
| 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 Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Niacinamide Niacin Nicotinic Acids Sevelamer Vitamin B Complex Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Chelating Agents |
ClinicalTrials.gov processed this record on June 17, 2013