Evaluation of the safety and equivalence of serum phosphate control of a sevelamer carbonate tablet formulation in comparison with Renvela® in chronic kidney disease patients on hemodialysis MedDRA version: 14.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: SVL (TEST)
Pharmaceutical Form: Tablet
INN or Proposed INN: SEVELAMER CARBONATE
CAS Number: 845273-93-0
Current Sponsor code: n/a
Other descriptive name: SEVELAMER CARBONATE
Concentratio
Sponsors
Synthon BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male and female Caucasian patients aged =18 years. Women of childbearing potential must have a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control (see paragraph 8.2), or female patients must be either post-menopausal for =1 year or surgically sterilised [2] Stable maintenance hemodialysis regarding frequency (2 or 3 times per week) and dialysis parameters (e.g. average duration, type of dialyzer) for at least 3 months [3] Life expectancy of at least 12 months [4] At screening for patients not receiving previous treatment with phosphate binders or after 2 weeks wash-out for patients who had previous therapy with phosphate binders: Serum phosphorus =1.78 mmol/l (=5.5 mg/dl) [5] Intact parathyroid hormone (iPTH) =87 pmol/l (=800 pg/ml) [6] Patients on stable diet and willing to follow stable diet [7] Patients with ability to follow study instructions and likely to attend and complete all required visits [8] Written informed consent of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [1] Hypersensitivity to sevelamer or to any of the excipients of the study drugs [2] Poorly controlled diabetes mellitus (HbA1c >11%) [3] Poorly controlled hypertension (blood pressure higher than 150/90 mm Hg) [4] Iron overload: serum ferritin >800 ng/ml combined with TSAT >50% [5] Swallowing disorder (dysphagia) [6] Bowel obstruction [7] Gastrointestinal motility disorders including: - untreated or severe gastroparesis, - diverticulosis, - retention of gastric contents, or - abnormal or irregular bowel motion. [8] Active inflammatory bowel disease [9] History of clinically relevant gastrointestinal surgery (excluding minor surgery, such as uncomplicated appendectomy, polypectomy or non-intestinal tract abdominal surgery, such as cholecystectomy) [10] Severe vomiting [11] Severe constipation [12] Concomitant malignancy (except carcinoma in situ not needing other than local therapy and basal cell carcinoma of the skin) [13] Use of: - antacids, - drugs that affect gastrointestinal motility, - ciprofloxacin, (unless this medicinal product is administered at least one hour before or 3 hours after sevelamer) - phosphate binders containing aluminium, magnesium, calcium or lanthanum for the duration of the study. A calcium supplement is acceptable if the dose remains unchanged between randomization and completion of the study, - levothyroxine, - anti-arrhythmic medication, - anti-seizure medication. [14] Active vasculitis [15] Alcohol /drug dependence or abuse (excluding tobacco abuse) [16] Pregnancy or lactation [17] Women of childbearing potential unable or unwilling to practice adequate contraceptive measures [18] Positive serologic findings for human immunodeficiency virus (HIV) antibodies [19] Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 1 month prior to start of the present study [20] Severe physical or mental concomitant diseases that might hamper the realisation of the trial according to protocol [21] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study [22] Unreliability or lack of cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Synthon sevelamer carbonate (SVL) compared to Renvela® (Genzyme) tablets in patients with CKD on hemodialysis based on the evaluation of the incidence of adverse events and serious adverse events as well as compliance.;Secondary Objective: To prove the equivalence of an oral test preparation containing 800 mg SVL as compared to Renvela® on the control of serum phosphorus in chronic kidney disease patients on hemodialysis;Primary end point(s): Incidence of treatment-emergent adverse events and percentage of subjects who withdrew due to adverse events;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: a) Time-weighted mean of the serum phosphorus concentration (determined from 4 measurements during the last 2 weeks of each 8-week double-blind treatment period) after treatment with the test and the reference product Safety: a) Clinically relevant changes in vital signs from baseline to the end of treatment b) Clinically relevant changes in safety laboratory parameters (hematology and biochemistry) from baseline to the end of treatment.;Timepoint(s) of evaluation of this end point: After completion of study and closure of data base. | — |
Countries
Bulgaria
Contacts
Public Contactclinical trial information
Synthon BV
Outcome results
None listed