Clinical Information
Rayaldee helped significantly more patients with stage 3 or 4 chronic kidney disease reduce intact parathyroid hormone (iPTH) by ≥30% from baseline and increase 25(OH)D to adequate levels (≥30 ng/mL), compared with placebo.1
Rayaldee significantly increased 25(OH)D levels1
Rayaldee significantly increased 25(OH)D levels1
Mean 25(OH)D levels over time in clinical trials1*
Increased 25(OH)D levels were associated with corresponding increases in 1,25D levels2
Patients achieving target 25(OH)D levels (≥30 ng/mL) at week 261
Average steady-state 25(OH)D levels ≥50 ng/mL
Rayaldee effectively reduced intact parathyroid hormone1*
Rayaldee effectively reduced intact parathyroid hormone1*
Mean iPTH levels over time in clinical trials*
iPTH levels declined over time with Rayaldee compared to placebo treatment (P<0.001)1*
Mean iPTH change from baseline1
Patients achieving iPTH response
(≥30% change from baseline to end of trial)1*
Study 1 (N=213) | Study 2 (N=216) | |
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Rayaldee arm (% of patients) | 33 | 34 |
Placebo arm (% of patients) | 8 | 7 |
The effect of Rayaldee on serum calcium and phosphorus was similar to placebo1*
The effect of Rayaldee on serum calcium and phosphorus was similar to placebo1*
Mean serum calcium over time in clinical trials1†
Mean serum phosphorus over time in clinical trials1†
* | Patients randomized to Rayaldee had a greater mean (SE) increase in calcium and phosphorus than patients randomized to placebo (Calcium: Rayaldee 0.2 [0.02] mg/dL versus placebo 0.1 [0.03] mg/dL [P<0.001]; Phosphorus: Rayaldee 0.2 [0.03] mg/dL versus placebo 0.1 [0.04] mg/dL). A total of 4.2% of Rayaldee-treated subjects and 2.1% of placebo-treated subjects had at least 1 elevation in calcium above the upper limit of normal (10.5 mg/dL). A total of 45% of Rayaldee-treated subjects and 44% of placebo-treated subjects had at least 1 elevation in phosphorus above the upper limit of normal (4.5 mg/dL).1 |
Clinical trials have demonstrated a safety profile for Rayaldee similar to placebo1,2
Clinical trials have demonstrated a safety profile for Rayaldee similar to placebo1,2
Common Adverse Reactions in Phase 3 Placebo-Controlled Trials Reported in ≥1.4% of Rayaldee-Treated Subjects
Adverse Reactions |
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Anemia |
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Nasopharyngitis |
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Blood creatinine increased |
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Dyspnea |
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Cough |
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Cardiac failure congestive |
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Constipation |
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Bronchitis |
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Hyperkalemia |
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Osteoarthritis |
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Hyperuricemia |
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Contusion |
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Pneumonia |
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Chronic obstructive pulmonary disease |
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Abbreviations
1,25D=1,25-dihydroxyvitamin D; 25(OH)D=25-hydroxyvitamin D; CKD=chronic kidney disease; CV=cardiovascular; iPTH=intact parathyroid hormone; SHPT=secondary hyperparathyroidism.
References: 1. Sprague SM, Crawford PW, Melnick JZ, et al. Use of extended-release calcifediol to treat secondary hyperparathyroidism in stages 3 and 4 chronic kidney disease. Am J Nephrol. 2016;44(4):316-325. 2. Rayaldee [package insert]. Miami, FL: OPKO Pharmaceuticals, LLC; June 2016.