Conditions: Hyperphosphataemia
Keywords: Dialysis Dependent Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief summary:
The main purpose of this study is to see whether PT20 can help people with a high level of phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for kidney disease.

Detailed description:
PT20 represents a mechanism to address many of the limitations associated with current phosphate binding agents. The available clinical and non clinical evidence suggests that PT20 binds phosphate and prevents its uptake more efficiently than other phosphate binding drugs and may therefore either reduce the pill burden associated with controlling phosphate levels, or result in lower phosphate levels with the same pill burden.

The this study is the first to investigate the efficacy and safety of PT20 in subjects with dialysis-dependent chronic kidney disease (CKD).

Arms:
arm 1: PT20 400 mg tid (1.2 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 2: PT20 800 mg tid (2.4 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 3: PT20 1600 mg tid (4.8 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 4: PT20 3200 mg tid (9.6 g/day) administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study arm 5: Matched Placebo (for PT20) tid administered orally.

Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study

Interventions: intervention 1: PT20 intervention 2: Placebo
Intervention descriptions: intervention 1: Modified ferric oxide adipate tablets intervention 2: Placebo tablets matched to each PT20 dose arm

Protocol document: