An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients (TOSCANA)

An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients

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)

Study Overview

• Status: Completed
• Conditions: Renal Failure Chronic
• Intervention / Treatment: Drug: sevelamer carbonate 800mg; Drug: sevelamer carbonate 2.4 g

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Russia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: Renvela

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	up to 8 weeks

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 16, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: SVCARB10012; U1111-1160-6394 (Other Identifier: UTN)