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Clinical Trial Details

Trial ID: L0310
Source ID: NCT01011699
Associated Drug: Nicotinamide
Title: Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
Acronym: NICOREN
Status: TERMINATED
Study Results: NO
Results:
Conditions: Chronic Renal Failure|Hemodialysis
Interventions: DRUG: nicotinamide|DRUG: sevelamer|DRUG: cinacalcet
Outcome Measures: Primary: 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 ®., 6th months | Secondary: 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)., 6 th months and one year|To evaluate the difference between nicotinamide and sevelamer on vascular calcification, one year|To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk, one year|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, 6th months|Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study, 6th months and one year|Compare the cost-effectiveness ratio of these two treatments, one year
Sponsor/Collaborators: Sponsor: Centre Hospitalier Universitaire, Amiens
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 176
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-01
Completion Date: 2013-06
Results First Posted:
Last Update Posted: 2016-05-16
Locations: Centre Hospitalier Général, Soissons, Aisne, 02009, France|Centre Hospitalier, Lisieux, Calvados, 14100, France|ALURAD, Limoges, Limousin, 87042, France|Centre Hospitalier Universitaire, Reims, Marne, 51092, France|Association Régionale Promotion Dialyse à domicile (ARPDD), Reims, Marne, France|Association pour le Développement de l'Hémodialyse, Hénin-Beaumont, Nord-Pas de Calais, 62110, France|Polyclinique de la Louvière, Lille, Nord, 59000, France|CHRU, Lille, Nord, 59037, France|Hôpital Victor Provo, Roubaix, Nord, 59056, France|Centre Hospitalier Général, Valenciennes, Nord, 59322, France|Centre Hospitalier Général, Beauvais, Oise, 60000, France|Clinique Saint Côme, Compiegne, Oise, 60200, France|Centre Hospitalier Général, Creil, Oise, 60100, France|Clinique du Bois Bernard, Bois Bernard, Pas de calais, 62320, France|Centre Hospitalier, Boulogne sur mer, Pas de calais, 62200, France|Centre Hospital-Universitaire d'Amiens, Amiens, Picardie, 80054, France|Clinique de l'Europe, Rouen, Seine maritime, 76040, France|Centre Hospitalier, Cambrai, 59407, France
URL: https://clinicaltrials.gov/show/NCT01011699

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D409 Nicotinamide small molecule DB02701 Details