Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

NCT01011699 | Terminated Phase 3

• 2 other identifiers: PHRCIR08-PR-FOURNIEREudract N°2008-004673-17
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Chronic Renal Failure; Hemodialysis

Keywords

nicotinamide; sevelamer hydrochloride; phosphatemia; cinacalcet; dyslipidemia; vascular calcification; bone mass loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

sevelamer

ACTIVE COMPARATOR

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; Drug: cinacalcet

nicotinamide

ACTIVE COMPARATOR

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; Drug: cinacalcet

Interventions

nicotinamide DRUG

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).

Also known as: Nicobion, ATC class A11HA01

nicotinamide

sevelamer DRUG

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).

Also known as: Renagel, ATC class V03AE02

sevelamer

cinacalcet DRUG

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.

Also known as: Mimpara, ATC class H05BX01

nicotinamide; sevelamer

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (18)

Centre Hospitalier Général

Soissons, Aisne, 02009, France

Location

Centre Hospitalier

Lisieux, Calvados, 14100, France

Location

Centre Hospitalier

Cambrai, Cambrai, 59407, France

Location

Association pour le Développement de l'Hémodialyse

Hénin-Beaumont, Hauts-de-France, 62110, France

Location

ALURAD

Limoges, Limousin, 87042, France

Location

Centre Hospitalier Universitaire

Reims, Marne, 51092, France

Location

Association Régionale Promotion Dialyse à domicile (ARPDD)

Reims, Marne, France

Location

Polyclinique de la Louvière

Lille, Nord, 59000, France

Location

CHRU

Lille, Nord, 59037, France

Location

Hôpital Victor Provo

Roubaix, Nord, 59056, France

Location

Centre Hospitalier Général

Valenciennes, Nord, 59322, France

Location

Centre Hospitalier Général

Beauvais, Oise, 60000, France

Location

Clinique Saint Côme

Compiègne, Oise, 60200, France

Location

Centre Hospitalier Général

Creil, Oise, 60100, France

Location

Clinique du Bois Bernard

Bois-Bernard, Pas de calais, 62320, France

Location

Centre Hospitalier

Boulogne-sur-Mer, Pas de calais, 62200, France

Location

Centre Hospital-Universitaire d'Amiens

Amiens, Picardie, 80054, France

Location

Clinique de l'Europe

Rouen, Seine maritime, 76040, France

Location

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MeSH Terms

Conditions

Kidney Failure, Chronic; Dyslipidemias; Vascular Calcification

Interventions

Niacinamide; Sevelamer; Cinacalcet

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcinosis; Calcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Polyamines; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Albert FOURNIER, Pr

  Centre Hospitalier Universitaire, Amiens

  STUDY DIRECTOR

• Ziad MASSY, Pr

  Centre Hospitalier Universitaire, Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

FR (18)