Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients (NICOREN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011699
Recruitment Status : Terminated (Financial problem)
First Posted : November 11, 2009
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Hemodialysis Drug: nicotinamide Drug: sevelamer Drug: cinacalcet Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients
Study Start Date : January 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sevelamer

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

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).

Other Names:
  • Renagel
  • ATC class V03AE02

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.

Other Names:
  • Mimpara
  • ATC class H05BX01

Active Comparator: nicotinamide

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

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).

Other Names:
  • Nicobion
  • ATC class A11HA01

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.

Other Names:
  • Mimpara
  • ATC class H05BX01




Primary Outcome Measures :
  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 ®. [ Time Frame: 6th months ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 6 th months and one year ]
  2. To evaluate the difference between nicotinamide and sevelamer on vascular calcification [ Time Frame: one year ]
  3. To evaluate the difference between nicotinamide and sevelamer on bone mass loss and fracture risk [ Time Frame: one year ]
  4. 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 [ Time Frame: 6th months ]
  5. Evaluate roles of metabolites of nicotinamide (efficacy and side effects) through another study [ Time Frame: 6th months and one year ]
  6. Compare the cost-effectiveness ratio of these two treatments [ Time Frame: one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011699


Locations
Show Show 18 study locations
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Layout table for investigator information
Study Director: Albert FOURNIER, Pr Centre Hospitalier Universitaire, Amiens
Principal Investigator: Ziad MASSY, Pr Centre Hospitalier Universitaire, Amiens
Publications:
Malluche M, Monier-faugère M, wang G, Frazao J, Coburn J, Baker N, McCary LC, Turner JA, Goodman WG: Cinaclacet Hcl reduces bone turn over and bone marrow fibrosa in hemodialysis patients with secondary hyperparathyroidism. ERA XLI congress. AbstractBook Lisboa:P218 (M016), 2004
Dament J,Gill M, Confer S, Jones C, Webster J: The bone kinetics of lanthanum in dialysis patient treated with lanthanum carbonate up to 45 years. J Am Soc Nephrol 15 (Abstract):271A (poster FPO 948), 2004
Malluche M, Faugère MC, Damment SJP, Webster I: No osteomalacia in dialysis patients treated with lanthanum carbonate up to 4.5 years. J Am Soc Nephrol 15 (supplt Abstract):p270A Poster F P0944,2004
De Smet R, Thermote F, Lameire N, Vanholder R: SEVELAMER hydrochloride (Renagel(r)) adsorbs the uremic compounds indoxyl sulfate, indole and p-creso.[Abstract]. J Am Soc Nephrol 15, 2004
Alsheikh-Ali A, Aboujaily HM, Stanek LJ, coll. e: Increases in HDL cholesterol are the strongest predictions of risk reduction in lipid intervention trials. Circulation 111 (suppltIII):813 Abstract 3754,2004

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01011699    
Other Study ID Numbers: PHRCIR08-PR-FOURNIER
Eudract N°2008-004673-17 ( Other Identifier: AFSSAPS )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016
Keywords provided by Centre Hospitalier Universitaire, Amiens:
nicotinamide
sevelamer hydrochloride
phosphatemia
cinacalcet
dyslipidemia
vascular calcification
bone mass loss
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Niacinamide
Niacin
Nicotinic Acids
Sevelamer
Cinacalcet
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vasodilator Agents
Calcium-Regulating Hormones and Agents
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists