Clinical trial NCT02332811: An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
Official title: An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Failure Chronic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russia
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: