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Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Information source: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Renal Failure; Hemodialysis

Intervention: nicotinamide (Drug); sevelamer (Drug); cinacalcet (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire, Amiens

Official(s) and/or principal investigator(s):
Albert FOURNIER, Pr, Study Director, Affiliation: Centre Hospitalier Universitaire, Amiens
Ziad MASSY, Pr, Principal Investigator, Affiliation: Centre Hospitalier Universitaire, Amiens

Overall contact:
Albert FOURNIER, Pr, Phone: +33 3 22 45 58 41, Email: Fournier.Albert@chu-amiens.fr

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.

Clinical Details

Official title: Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 ®.

Secondary outcome:

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).

To evaluate the difference between nicotinamide and sevelamer on vascular calcification

To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk

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

Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study

Compare the cost-effectiveness ratio of these two treatments

Detailed description: This is a multicenter randomized open study with 2 treatment arms (nicotinamide / Sevelamer). Laboratories who will dose biochemical parameters and PTH, ignore which treatment is received by patients. The team which will measure bone density and the radiologist or rheumatologist who will appreciate centrally calcification and deformity of the vertebrae, ignore which treatment is received by patients. Therefore it's a Randomized Prospective Blinded Outcome Endpoint. Pre-recruitment period (3 to 6 months) with basic medication

- Repletion of vitamin D (p 25 OHD between 30 and 50 ng / ml) (if required by

supplementation Dedrogyl weekly by the dialysis nurse)

- Bath dialysis to 1. 50 mmol / l calcium (1. 75 mmol / l if hemodiafiltration), 32 mmol

bicarbonate and 0. 5 mmol / l magnesium - Support to provide a dietary protein intake

with 1. 2 g / kg / d and assessment of contributions of Ca and PO4

- Use of CaCO3 taken with meals rich in phosphorus (morning, noon and evening) without

- In case of hyperkalemia, Calcium Sorbisterit® will preferably be used instead of

KAYEXALATE®. This process exposes the worsening effect of hyperphosphatemia increasing calcium malabsorption and therefore the negative calcium balance in renal failure.

- Statin therapy, fibrate or ezetimibe if necessary, but with stable dose

This treatment will be monitored on the following parameters:

- Biochemical weekly Predialytic (midweek): creatinine, urea, PO4, Ca, protein, Na, K,

bicarbonate, glucose, uric acid

- Additional monthly balance: PTH intact, Mg, albumin, CRP

- Each 4 months update: lipid profile (fasting or not, but always at the same time, 25 OH

D, complete blood count (CBC), AST-ALT, total alkaline phosphatase, gamma-GT, PKC, glycated hemoglobin (HbA1C) ) Recruitment (180 patients):

- Obtaining informed consent

- Perform a bone density by DXA third of the radius (cortical bone), radius ultradistal

(trabecular bone), femoral neck bone (mixed), whole body and lumbar spine profile radiography.

- Lumbar and dorsal radiography (frontal and profile) for research and vertebral

measurement of aortic calcification by the Framingham score) + pelvis radiography (frontal) and 2 hands radiography (frontal) searching vascular calcification, Looser's streaks and subperiosteal resorption.

- Freezing at -80 ° C (4 tubes of 1 ml of serum)for centralized analysis: PTH, 25 OHD,

CTX, PAO. All samples will be sent for laboratory analysis of Biochemistry University Hospital of Amiens at the end of the study. For this, 10 ml of blood will be collected with a dry tube then centrifuged 15 minutes, 4000-5000 rpm at room temperature within 30 minutes after collection. Then, aliquot 1ml into 4 polypropylene tubes being careful not to take the fibrin.

- Freezing at -80 ° C in a tube of 2. 5 ml of plasma to be assayed later the metabolites

of nicotinamide. These samples will only be achieved if patients accept and mark the second part of the consent. The tubes are then stored in the biological resource center, CHU Amiens for further research and for an indefinite period. The nicotinamide metabolites measured in this study will annex the Met2PY (N-methyl-2-pyridone-5-carboxamide), the Met4PY (N-methyl-4-pyridone-3-carboxamide) and NAD (nicotinamide adenine dinucleotide). 6 ml of EDTA whole blood will be collected, then centrifuged 15 minutes, 4000-5000 rpm at room temperature within 30 minutes after collection. Then, 2. 5 ml aliquot in 1 polypropylene tube.

- Then a heparinized blood sample of 2. 5 ml will be frozen at -80 °C for determination of

nicotinamide. All samples will be sent for analysis at CERBA at the end of the study. Randomization will be done by the minimization technic with stratification factors: center, duration of dialysis and taking lipid lowering therapy. Randomization will be performed remotely via a website. Follow-up of one year:

- Period titration nicotinamide or sevelamer to control serum phosphorus in 4 weeks, with

stable doses of CaCO3

- Increased nicotinamide 500 mg up to 4 tablets: 0-1-0, 0-1-1, 1-1-1, 1-2-1

- Increased sevelamer 800 mg up to 12 tablets: 0-2-2 ; 2-4-4 ; 4-4-4 ; 2-5-5

- Maintenance period of 5 months with assessment of maintenance doses of Renagel

(sevelamer) or Nicobion (nicotinamide) or during the last 3 months.

- After these 6 months:

- Freezing -80 ° C, 4 tubes of 1 ml of serum centralized reviews PTH, 25 OHD, CTX, PAO

(as mentioned above).

- Freezing -80 ° C in a tube of 2. 5 ml of plasma to be assayed later the metabolites of

nicotinamide (as mentioned above).

- Freezing -80 ° C with a heparinized blood sample of 2. 5 ml for determination of

nicotinamide (as mentioned above).

- Second randomization via a website, patients with intact PTH> 300 pg / ml after 6

months of Nicobion ® and Renagel ®. Randomization 75-150 pg / ml or 150-300 mg / ml will be made by the minimization technic with stratification factors: the center and the type of Hypophosphatemia PTH will be reduced by introducing cinacalcet ® by increments of 30 mg every 3 weeks to 180 mg / day (given with meals 24 hours before the next dialysis). Increase of Cinacalcet ® will be stopped when PTH is <250 pg / ml for arm 150-300pg/ml or <125 per arm 75-150 pg / ml. Once corrected calcemia <2. 25 mmol / l, doses of CaCO3 will be increased; if the maximum tolerable of CaCO3 on the tract map does not prevent hypocalcemia (<2. 10 mmol / l), the calcium bath will be increased to 1. 75 mmol / l CaCO3 decreased and, if necessary adjustment of nicotinamide / Sevelamer to maintain PO4 between 1. 30 and 1. 60 mmol / l.

- During the first 6 months of administration of sevelamer, weekly, monthly and quarterly

reports will be done. Regarding PTH assay will be performed, every 3 weeks during the titration of cinacalcet.

- A lumbar and dorsal radiography (frontal and profile), a pelvis radiography (face) and

2 hands radiography (front) will be conducted at the end of follow-up period.

- Bone densitometry will be performed at the end of the study (same camera - same site).

- Case report form: tolerance, serious adverse events, compliance, cardiovascular events

(myocardial infarction, PAO, stroke, arteritis, vascular intervention),deaths and fractures during the follow-up study.

- Freezing -80 ° C to 4 tubes of 1 ml of serum centralized reviews PTH, 25 OHD, CTX, PAO

at the end of the study (as mentioned above).

- Freezing -80 ° C in a tube of 2. 5 ml of plasma to be assayed later the metabolites of

nicotinamide at the end of the study (as mentioned above).

- Freezing at -80 ° C with a heparinized blood sample of 2. 5 ml for determination of

nicotinamide at the end of the study (as mentioned above). Analytical Methodology

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Albert FOURNIER, Pr, Phone: +33 3 22 45 58 41, Email: Fournier.Albert@chu-amiens.fr

Centre Hospitalier, Cambrai 59407, France; Recruiting
Guy DEGREMONT, Dr, Phone: + 33 3 27 73 73 33
Guy DEGREMONT, Dr, Principal Investigator
Bernard PAINCHART, Dr, Sub-Investigator

Centre Hospitalier Général, Soissons, Aisne 02009, France; Recruiting
Janette MANSOUR, Dr, Phone: + 33 3 23 75 72 77, Email: Janette.mansour@ch-soissons.fr
Bertin EBIKILI, Dr, Phone: + 33 3 23 75 72 77, Email: sect.hemodialyse@ch-soissons.fr
Bertin EBIKILI, Dr, Sub-Investigator
Janette MANSOUR, Dr, Principal Investigator
Badri MATA, Dr, Sub-Investigator
Aimé Rémy BOULA, Dr, Sub-Investigator

Centre Hospitalier, Lisieux, Calvados 14100, France; Active, not recruiting

ALURAD, Limoges, Limousin 87042, France; Recruiting
Carine ACHARD, Dr, Phone: + 33 5 55 43 17 40
Carine ACHARD, Dr, Principal Investigator

Association Régionale Promotion Dialyse à domicile (ARPDD), Reims, Marne, France; Recruiting
Andréea PETRACHE, Dr, Phone: +33 3 26 77 67 90, Email: andreea.petrache@arpdd.asso.fr

Centre Hospitalier Universitaire, Reims, Marne 51092, France; Recruiting
Philippe RIEU, Dr, Phone: +33 3 26 78 76 30, Email: prieu@chu-reims.fr
Hervé MAHEUT, Dr, Phone: + 33 3 26 78 76 30, Email: hmaheut@chu-reims.fr
Philippe RIEU, Dr, Principal Investigator
Hervé MAHEUT, Dr, Sub-Investigator
Isabelle KAZES, Dr, Sub-Investigator
Andréea PETRACHE, Dr, Sub-Investigator

CHRU, Lille, Nord 59037, France; Recruiting
François-Xavier GLOWACKI, PU PH, Phone: + 33 3 20 44 59 62, Email: f.glowacki@chru-lille.fr
Célia LESSORE DE SAINTE FOY, PH, Phone: + 33 3 20 44 57 25, Email: c.lessore@chru-lille.fr
François-Xavier GLOWACKI, PU PH, Principal Investigator
Célia LESSORE DE SAINTE FOY, PH, Sub-Investigator

Polyclinique de la Louvière, Lille, Nord 59000, France; Recruiting
Nasser HAMDINI, Dr, Phone: +33 3 20 15 71 31, Email: hemodialyse@wanadoo.fr
Nasser HAMDINI, Dr, Principal Investigator

Hôpital Victor Provo, Roubaix, Nord 59056, France; Not yet recruiting
Hervé LE MONIES DE SAGAZAN, Dr, Phone: + 33 3 20 99 31 81, Email: h.lemonies@wanadoo.fr
Jean-Christophe SZELAG, Dr, Phone: + 33 3 20 99 31 81, Email: jean-christophe.szelag@ch-roubaix.fr
Hervé LE MONIES DE SAGAZAN, Dr, Principal Investigator
Jean-Chrsitophe SZELAG, Dr, Sub-Investigator

Centre Hospitalier Général, Valenciennes, Nord 59322, France; Active, not recruiting

Association pour le Développement de l'Hémodialyse, Hénin-Beaumont, Nord-Pas de Calais 62110, France; Active, not recruiting

Centre Hospitalier Général, Beauvais, Oise 60000, France; Recruiting
Guy LAMBREY, Dr, Phone: + 33 3 44 11 23 44, Email: g.lambrey@ch-beauvais.fr
Henry RENAUD, Dr, Phone: +33 3 44 11 23 44, Email: h.renaud@ch-beauvais.fr
Guy LAMBREY, Dr, Principal Investigator
Henry RENAUD, Dr, Sub-Investigator
Patrick FOHRER, Dr, Sub-Investigator
Larbi LAMRIBEN, Dr, Sub-Investigator

Clinique Saint Côme, Compiegne, Oise 60200, France; Active, not recruiting

Centre Hospitalier Général, Creil, Oise 60100, France; Active, not recruiting

Clinique du Bois Bernard, Bois Bernard, Pas de calais 62320, France; Active, not recruiting

Centre Hospitalier, Boulogne sur mer, Pas de calais 62200, France; Recruiting
Pierre BATAILLE, Dr, Phone: +33 3 21 99 30 51, Email: p.bataille@ch-boulogne.fr
Milad SHENOUDA, Dr, Phone: +33 3 21 99 30 51, Email: miladsam@link.net
Pierre BATAILLE, Dr, Principal Investigator
Milad SHENOUDA, Dr, Sub-Investigator

Centre Hospital-Universitaire d'Amiens, Amiens, Picardie 80054, France; Recruiting
Albert FOURNIER, PU PH, Phone: + 33 3 22 45 58 41, Email: Fournier.Albert@chu-amiens.fr
Ziad MASSY, PU PH, Phone: +33 3 22 45 57 85, Email: Massy.ziad@chu-amiens.fr
Ziad MASSY, PU, PH, Sub-Investigator
Najeh EL ESPER, PH, Sub-Investigator
Albert FOURNIER, PU PH, Principal Investigator
Gabriel CHOUKROUN, PU PH, Sub-Investigator

Clinique de l'Europe, Rouen, Seine maritime 76040, France; Active, not recruiting

Additional Information

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Starting date: January 2010
Last updated: February 22, 2012

Page last updated: August 23, 2015

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