Phase 2
N=153
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Hyperphosphataemia
Bottom Line
View on ClinicalTrials.gov: NCT02151643 ↗Enrolled (actual)
153
Serious AEs
8.5%
Results posted
Jan 2018
Primary outcome: Primary: Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) — -0.4; -0.59; -1.29; -1.363 mg/dL — p=0.784
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PT20 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Phosphate Therapeutics
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
-0.4; -0.59; -1.29; -1.363; -0.165 | 0.784 |
| SECONDARY Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
0.02; -0.25; -0.22; 0.18; -0.13 | 0.497 |
| SECONDARY Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
50; 48.8; 10.1; 69.9; -67.0 | 0.243 |
| SECONDARY Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
2.20; 0.40; 5.84; -4.59; -0.45 | 0.068 |
| SECONDARY Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
-5.515; -4.035; -11.127; -10.996; -0.778 | 0.004 sig |
| SECONDARY Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
-0.9; 2.8; 0.4; 1.6; 0.1 | 0.292 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02151643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.