Hyperphosphatemia in patients with chronic kidney disease on maintenance hemodialysis MedDRA version: 9.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia
Conditions
Interventions
Product Name: PA21
Product Code: YT325
Pharmaceutical Form: Chewable tablet
Current Sponsor code: XR500
Other descriptive name: PA21
Concentration unit: g gram(s)
Concentration type: equal
Concentrati
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent. 2. Men and women = 18 years of age, 3. Receiving stable maintenance hemodialysis 3 times a week for = 3 months before screening, 4. Being on restricted phosphate diet at screening and throughout study, and being compliant with prescribed phosphate binders, as per Investigator judgment, 5. Receiving stable doses of phosphate binder for at least 1 month before screening, 6. Patients receiving therapy with vitamin D, vitamin D metabolites or calcimimetics must be on a constant dose for a least 1 month prior to screening and must remain on the same dose throughout the study, 7. Having stable calcium content in dialysate for at least 1 month prior to screening, 8. Able to read and write with sufficient competence to understand the study procedures and capable of giving legal consent, 9. Patients who receive therapy with erythropoietin must be on a stable (± 25% dose adjustments compared to dose at screening) dose for at least 1 month before screening and must remain on a stable dose (± 25% dose adjustments, compared to dose at Week 1, D1) throughout the study, To be eligible for randomization and to enter into the treatment period, the patients must have: 10. Serum phosphate levels > 1.78 mmol/L (5.5 mg/dL) (Value at Week -1, D2 or D3). If the serum phosphate level is > 1.78 mmol/L (> 5.5 mg/dL) already at Week 1, D2, then the patient can be randomized (in Week 1, D1) based on the values of Week 1, D2 even if the level at Week -1, D3 is = 1.78 mmol/L (= 5.5 mg/dL). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients cannot be enrolled in this study if they meet one or more of the following exclusion criteria: 1. Uncontrolled hyperphosphatemia (>2.5 mmol/L [7.75 mg/dL]) while on conventional phosphate binders (value at screening), 2. Hypercalcemia (serum calcium >2.5 mmol/L [>10.0 mg/dL]) at screening or during washout, 3. Serum calcium 600 ng/L) at screening, 5. Intention to initiate therapy with vitamin D, vitamin D metabolites or calcimimetics during the study or / and non-stable therapy with vitamin D, vitamin D metabolites or calcimimetics (if applicable), 6. Known history of non-response to phosphate binders, 7. Known hypersensitivity to PA21, sevelamer (as Renagel® or Renvela®), or to any of their excipients, or iron allergy, 8. Pregnancy or lactation (patients with a positive pregnancy test will leave the study and may be rescreened once about 2 weeks after the first pregnancy test, to rule out a false positive pregnancy test), 9. Iron deficiency anemia defined as hemoglobin 3 times the upper limit of the normal range at screening), 15. Known seropositivity to human immunodeficiency virus (HIV), 16. Active infection or is being treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the ability of different doses of PA21 to lower serum phosphate levels in patients with chronic kidney disease on maintenance hemodialysis.;Secondary Objective: To assess the efficacy/safety profiles of the different doses of PA21.;Primary end point(s): Change from baseline in serum-phosphate levels at the end of treatment. | — |
Countries
Bulgaria, Czech Republic, Germany
Outcome results
None listed