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

Renal Failure Chronic Clinical Trial

— TOSCANA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332811
• Other study ID #: SVCARB10012
• Secondary ID: U1111-1160-6394
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2014
• Last updated: December 22, 2016
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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)

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency

Intervention

Drug:
• sevelamer carbonate 800mg
Pharmaceutical form:tablet Route of administration: oral
• sevelamer carbonate 2.4 g
Pharmaceutical form:powder Route of administration: oral

Locations

Country	Name	City	State
Russian Federation	Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No