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

Genzyme

Status and phase: Completed; Phase 3

Conditions: Renal Failure Chronic

Treatments: Drug: sevelamer carbonate 800mg; Drug: sevelamer carbonate 2.4 g

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332811

SVCARB10012

U1111-1160-6394 (Other Identifier)

Details and patient eligibility

About

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)

Full description

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

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 4 patient groups

CKD patients not on dialysis 800 mg

Experimental group

Description:

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Treatment:

Drug: sevelamer carbonate 800mg

CKD patients not on dialysis 2.4 g

Experimental group

Description:

Sevelamer carbonate 2.4 g powder carbonate per day

Treatment:

Drug: sevelamer carbonate 2.4 g

CKD patients on dialysis 800 mg

Experimental group

Description:

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Treatment:

Drug: sevelamer carbonate 800mg

CKD patients on dialysis 2.4 g

Experimental group

Description:

Sevelamer carbonate 2.4 g powder carbonate per day

Treatment:

Drug: sevelamer carbonate 2.4 g