Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 150
Inclusion Criteria
- Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
- Men or women aged 18 90 years
- 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.
- Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
- Men or women aged 18 90 years
- 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.
- 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.
Summary
- Conditions
- Hyperphosphataemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
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 re...
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).
Inclusion Criteria
- Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
- Men or women aged 18 90 years
- 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.
- Subject must have a stable dialysis prescription for at least 28 days prior to start of Screening.
- Men or women aged 18 90 years
- 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.
- 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.
Tracking Information
- NCT #
- NCT02151643
- Collaborators
- Clinipace Worldwide
- Investigators
- Principal Investigator: Geoff Block, MD Denver Nephrologist
- Geoff Block, MD Denver Nephrologist
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