A study to demonstrate the equivalence of Sevelamer carbonate tablet 800 mg, (Test Drug) with Renvela® 800 mg (Reference drug)in adult patients of hyperphosphataemia receiving haemodialysis.
- Conditions
- Health Condition 1: E833- Disorders of phosphorus metabolismand phosphatases
- Registration Number
- CTRI/2012/03/002501
- Lead Sponsor
- Pharmathen SA Dervenakion str
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 80
1.Informed consent should be obtained before any trial-related activities.
2.Male or female aged >=18 years.
3.Patients who are eligible for Sevelamer carbonate as per principal Investigator discretion.
4.Patient should have the following documented laboratory measurements:
-Two most recent consecutive serum phosphorus measurements that are >= 3.0 and <= 7.5 mg/dL within 60 days of screening
-An most recent iPTH measurement <= 900 pg/mL ( < 99 pmol/L) within 90 days of screening
-A serum phosphorus measurement >= 5.5 mg/dL (>= 1.76 mmol/L at local lab) at Visit 2 (after Washout period and before run-in period)
1.Known hypersensitivity to Sevelamer or any of its components
2.Pregnant, breast-feeding female
3.Have active dysphagia, swallowing disorders, bowel obstruction, or severe gastrointestinal motility disorders.
4.Have any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion
5.Have participated in a study of an investigational drug during the 30 days preceding the start of the run in period
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the therapeutic equivalence of Sevelamer carbonate tablets (Test drug) with Renvela (Sevelamer Carbonate Tablets) on the control of serum phosphorus levelTimepoint: NA
- Secondary Outcome Measures
Name Time Method To monitor the safety of the patients who are exposed to investigational medicinal productsTimepoint: NA