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Trial record 1 of 1 for:    NCT02332811
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An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients (TOSCANA)

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: NCT02332811
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:

Primary Objective:

Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis

Secondary Objective:

Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)


Condition or disease Intervention/treatment Phase
Renal Failure Chronic Drug: sevelamer carbonate 800mg Drug: sevelamer carbonate 2.4 g Phase 3

Detailed Description:
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: CKD patients not on dialysis 800 mg
Sevelamer carbonate 800 mg in tabs 3 times per day with meals
Drug: sevelamer carbonate 800mg

Pharmaceutical form:tablet

Route of administration: oral

Other Name: Renvela

Experimental: CKD patients not on dialysis 2.4 g
Sevelamer carbonate 2.4 g powder carbonate per day
Drug: sevelamer carbonate 2.4 g

Pharmaceutical form:powder

Route of administration: oral

Other Name: Renvela

Experimental: CKD patients on dialysis 800 mg
Sevelamer carbonate 800 mg in tabs 3 times per day with meals
Drug: sevelamer carbonate 800mg

Pharmaceutical form:tablet

Route of administration: oral

Other Name: Renvela

Experimental: CKD patients on dialysis 2.4 g
Sevelamer carbonate 2.4 g powder carbonate per day
Drug: sevelamer carbonate 2.4 g

Pharmaceutical form:powder

Route of administration: oral

Other Name: Renvela




Primary Outcome Measures :
  1. The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis [ Time Frame: up to 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen

  • If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period
  • Willing to avoid any intentional changes in diet such as fasting or dieting
  • Have the following laboratory measurement:

    • iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening)
    • If not taking a phosphate binder, a serum phosphorus measurement >5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1).
    • If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0).
  • Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study
  • Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study
  • Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
  • If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices
  • For patients not on dialysis expecting not to initiate dialysis for the duration of this study
  • Signed informed consent
  • Has not participated in any other investigational drug studies within 30 days prior to enrollment
  • Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel

Exclusion criteria:

  • Active dysphagia or swallowing disorder
  • Predisposition or current bowel obstruction,
  • Severe gastrointestinal (GI) motility disorders including severe constipation
  • Active ethanol or drug abuse, excluding tobacco use
  • Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
  • In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
  • Planned renal transplant or parathyroidectomy within 3 months of Visit 1
  • Pregnant or breast-feeding
  • Evidence of active malignancy except for basal cell carcinoma of the skin
  • Unable to comply with the requirements of the study
  • Known hypersensitivity to sevelamer or any constituents of the study drug
  • Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT02332811


Locations
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Russian Federation
Russia
Moscow, Russian Federation
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02332811    
Other Study ID Numbers: SVCARB10012
U1111-1160-6394 ( Other Identifier: UTN )
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action