Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease

Phosphate Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperphosphataemia

Treatments: Drug: Placebo; Drug: PT20

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151643

PT20-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 153 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged 18 90 years
• Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
• Subject must have the most recent serum phosphate measurement, taken during the 28 days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

Exclusion criteria

• Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days prior to the start of Screening (Visit 1) is < 18 mg/dL.
• Subject has, in the opinion of the investigator, severe chronic lung disease and/or carbon dioxide retention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 5 patient groups, including a placebo group

Group 1 - PT20 400 mg tid

Experimental group

Description:

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

Treatment:

Drug: PT20

Group 2 - PT20 800 mg tid

Experimental group

Description:

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

Treatment:

Drug: PT20

Group 3 - PT20 1600 mg tid

Experimental group

Description:

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

Treatment:

Drug: PT20

Group 4 - PT20 3200 mg tid

Experimental group

Description:

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

Treatment:

Drug: PT20

Group 5 - Placebo tid

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo