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This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 Arm 1 | Experimental | EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2 |
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| Period 1 Arm 2 | Experimental | Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2 |
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| Period 2 Arm 1 | Experimental | EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2 |
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| Period 2 Arm 2 | Experimental | EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS789 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidences of adverse events | Incidences of adverse events | Up to Day 42 in each treatment sequence |
| Safety: Change from baseline in vital signs | Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) | Up to Day 42 in each treatment sequence |
| Safety: Change from baseline in clinical laboratory tests | Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation) | Up to Day 42 in each treatment sequence |
| Safety: Change from baseline in 12 lead ECGs | Change from baseline in 12 lead ECGs | Up to Day 42 in each treatment sequence |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma concentration of EOS789 | Day 4, 9, 10, 11 in the first treatment sequence in each period | |
| Pharmacokinetics: Total exposure (area under the curve [AUC]) | Day 10 in the first treatment sequence in each period |
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Inclusion Criteria:
- Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:
Exclusion Criteria:
- Patients with CKD and hyperphosphatemia who meet any of the following criteria will be excluded from study entry:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Leader | Chugai Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | United States |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Drug |
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| Renvela | Drug |
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| Pharmacokinetics: Maximum concentration (Cmax) | Day 10 in the first treatment sequence in each period |
| Pharmacokinetics: Time to reach Cmax (Tmax) | Day 10 in the first treatment sequence in each period |
| Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state | Day 9 in the first treatment sequence in each period |
| Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus | Days 11 to 13 in the first treatment sequence and second treatment sequence in each period |
| Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13 | Day 13 in the first treatment sequence and second treatment sequence in each period |