A study to demonstrate the equivalence of Sevelamer carbonate tablet 800 mg, (Test Drug) with RenvelaÂ® 800 mg (Reference drug)in adult patients of hyperphosphataemia receiving haemodialysis.

A Crossover, Multicentric Randomized study, in adult patients of hyperphosphataemia receiving haemodialysis to demonstrate equivalence of Sevelamer carbonate tablet 800 mg, manufactured by Pharmathen S.A. (Test Drug) with RenvelaÂ® 800 mg. (Sevelamer carbonate 800 mg, Genzyme Europe B.V, Gooimee 10,1411 DD Naarden The Netherlands)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002501

Enrollment

Registered

2012-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E833- Disorders of phosphorus metabolismand phosphatases

Interventions

Intervention1: Sevelamer carbonate tablet 800 mg, manufactured by Pharmathen S.A.: The recommended starting dose of Sevelamer carbonate is 800 to 1600 mg, which can be administered as one or two Sevel

Eligibility

Inclusion criteria

Inclusion criteria: 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 - An most recent iPTH measurement - 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To monitor the safety of the patients who are exposed to investigational medicinal productsTimepoint: NA	—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd.

praveenshetty@lambda-cro.com91-79-40202098

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026