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Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

NCT01011699 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2016-05-16

No results posted yet for this study

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

Interventions

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).

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).

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Albert FOURNIER, Pr · Centre Hospitalier Universitaire, Amiens

  • Ziad MASSY, Pr · Centre Hospitalier Universitaire, Amiens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011699 on ClinicalTrials.gov