Health Condition 1: E833- Disorders of phosphorus metabolismand phosphatases Health Condition 2: null- Indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis
Conditions
Interventions
Intervention1: Sevelamer Hydrochloride Tablets: Sevelamer Hydrochloride Tablets 800 mg Tablets Three times a day dose.
Control Intervention1: Renagel: Sevelamer Hydrochloride Tablets) 800 mg three tim
Sponsors
Waymade Plc
CRO Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility for Run-in Phase: eligble patient will receive Renagel 800mg tablet bottle of 87 tablets which are been taken orally for three times a day for 28 days. after run-in phase the patient will randomly put in to period 1 or period 2 for 8 weeks treatment, and as it is cross over study the total duration of study for patient eil be 5-6 months. 1. Male and female patients aged between 18 to 65 years. 2. Patients who are on stable hemodialysis for at least 3 months prior to screening. 3. For patients not treated with phosphate binders: Patient should have documented hyperphosphatemia with S-phosphorus >=1.78 mmol/l (5.5 mg/dl) at screening. 4. For patients treated with phosphate binders: Patient should have documented hyperphosphatemia with S-phosphorus >=1.78 mmol/l (5.5 mg/dl) after 2 weeks of wash-out period. Eligibility for Randomization: 5. Patient will be eligible for randomization, if all of the following criteriaâ??s are met: (1) Sevelamer dose should be stable for at least 1 week in run-in phase. (2) Serum phosphorus level >= 1 mmol/l (3.1 mg/dl) and (3) Intact parathyroid hormone (iPTH) (4) Stable dose of concomitant Vit D, Calcium or Cinacalcet. 6. Female patient of child bearing potential or sexually active male patient with partners of childbearing potential must practice acceptable contraception (e.g., condoms, intrauterine contraceptive devices) during treatment and at least 2 months after the last dose of treatment.
Exclusion criteria
Exclusion criteria: ï?§ History of known hypersensitivity to Sevelamer or any of its components. ï?§ Patientâ??s having active dysphagia, swallowing disorders, bowel obstruction or severe gastrointestinal motility disorders. ï?§ Patients have any evidence of active malignancy except for basal cell carcinoma of the skin. ï?§ Pregnant or lactating female patient or planning to become pregnant during the projected duration of the clinical trial or who cannot provide a credible history of reliable contraceptive practices. ï?§ The patients with poorly controlled diabetes mellitus, hypertension, active vasculitis, HIV infection or any clinically significant unstable medical condition as per Investigatorâ??s discretion. ï?§ Participated in any other clinical trial in the past 3 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The comparison of the time-weighted mean serum phosphorus level. Serum calcium x phosphorus product concentration. Timepoint: The comparison of the time-weighted mean serum phosphorus level. [Time frame: 4 measurements on hemodialysis visits during the last 2 weeks of each 8 weeks treatment period] Serum calcium x phosphorus product concentration. [Time frame: At the end of each 8 weeks treatment period] | — |
Primary
| Measure | Time frame |
|---|---|
| The incidence of Treatment Emergent Adverse Events (TEAEs). Percentage of patient withdrawal due to AEs.Timepoint: The incidence of Treatment Emergent Adverse Events (TEAEs). Percentage of patient withdrawal due to AEs. | — |
Countries
India
Contacts
Public ContactDr Akhil Sanghal
Cadila Pharmaceuticals Limited
Outcome results
None listed