Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Cinacalcet; Cinacalcet Hydrochloride; Niacin; Niacinamide; Nicotinic Acids; Sevelamer

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.