Clinical trial NCT02151643: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Official title: Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphataemia
Keywords: Dialysis Dependent Chronic Kidney Disease
Lead sponsor: Phosphate Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Clinipace Worldwide
First posted: 2014-05-30
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
Secondary outcomes:
measure: Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
measure: Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
measure: Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
measure: Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
measure: Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
timeFrame: Day 1 to Day 29
Other outcomes:
Locations:
Study officials:
affiliation: Denver Nephrologist
name: Geoff Block, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampson M, Faria N, Powell JJ; PEACH study investigators. Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease. Nephrol Dial Transplant. 2021 Jul 23;36(8):1399-1407. doi: 10.1093/ndt/gfaa116.