Control of hyperphosphataemia in patients with chronic kidney disease on dialysis MedDRA version: 15.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 15.0 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have completed treatment in Protocol PA-CL-05A (Stage 1 or Stage 2) (except subjects randomised to the PA21 low dose group of the Stage 2 primary efficacy assessment). 2. Subjects (or their legally acceptable representative) who have provided the appropriate written informed consent. Subjects must provide written informed consent before any study-specific procedures are performed including screening procedures. 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 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1. Subjects randomised to the PA21 low dose group of the Stage 2 primary efficacy assessment of Protocol PA-CL-05A. 2. Subjects with hypercalcaemia (total serum calcium >2.75 mmol/L or >11.00 mg/dL at the previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1, Week 26 for Stage 2)) (central laboratory values). 3. Subjects with hypocalcaemia (total serum calcium 3 times the upper limit of the normal range at the previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1, Week 24 for Stage 2) (central laboratory values). 5. Subjects taking any prohibited medications (see Section 7.7, Prohibited Therapy and Concomitant Treatment, page 41). 6. Subjects who are pregnant (e.g., positive human chorionic gonadotropin test at Week 20 Protocol PA-CL-05A), breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. Subjects must agree to use adequate contraception during the study and for 1 month after the last dose of the study medication. Adequate methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-childbearing potential includes being surgically sterilised at least 6 months prior to the study or post-menopausal, defined as amenorrhea for at least 12 months. 7. Subjects with serum ferritin >2,000 mcg/L (>4.494 pmol/L) at the previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1, Week 24 for Stage 2) (central laboratory values). 8. Subjects with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of PA21;Secondary Objective: To compare the long-term serum phosphate control of PA21 versus sevelamer carbonate To compare the safety and tolerability of PA21 versus sevelamer carbonate;Primary end point(s): Adverse events (AE) profile and routine biochemical/haematological laboratory tests;Timepoint(s) of evaluation of this end point: End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Comparison of the AE profiles of PA21 and sevelamer carbonate subjects •Serum calcium (total, corrected and ionised) at each time point andchange from entry into Protocol PA-CL-05B •Percentage of subjects that develop at least 1 episode of sustained hypercalcaemia (total serum calcium >2.75 mmol/L or >11.00 mg/dL) during study participation (confirmed by repeat sample 1 week later), despite "rescue" interventions •Serum calcium x phosphate product at each time point and change from entry into Protocol PA-CL-05B •Serum intact parathyroid hormone levels at each time point and change from entry into Protocol PA-CL-05B •Biochemical (including liver function tests) and haematological laboratory tests •Iron status: iron, ferritin, transferrin and transferrin saturation •Biochemical markers of bone resorption and formation • Vitamin status (A, D, E and K);Timepoint(s) of evaluation of this end point: End of Study | — |
Countries
Austria, Belgium, Croatia, Czech Republic, Germany, Latvia, Lithuania, Poland, Romania, Russian Federation, Serbia, South Africa, Sweden, Switzerland, Ukraine, United Kingdom, United States
Contacts
Public ContactMichael Bauer
Vifor (International) Inc.
Outcome results
None listed