Phase 2
N=162
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT02081534 ↗Enrolled (actual)
162
Serious AEs
8.6%
Results posted
Sep 2020
Primary outcome: Primary: Change in Serum Phosphate Levels — -.47; -1.18; -1.7; -1.98 mg/dL — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD1722 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardelyx
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Phosphate Levels |
-.47; -1.18; -1.7; -1.98; -.56; -1.11 | 0.012 sig |
| SECONDARY Change From Baseline in Calcium x Phosphorus Product |
-5.16; -12.02; -12.44; -16.6; -3.59; -11.02 | — |
Summary
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
Eligibility Criteria
Inclusion Criteria
- Females and males aged ≥18 years
- Chronic maintenance hemodialysis 3 x/week for a at least 3 months
- Prescribed and taking at least 3 doses of phosphate binder per day
- Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
- Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
- For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out
Exclusion Criteria
- Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
- Serum parathyroid hormone >1200 pg/mL
- Significant metabolic acidosis
- Clinical signs of hypovolemia at randomization
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Data sourced from ClinicalTrials.gov (NCT02081534). 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.