Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nicotinamide · 1 trial · 1 indication
Change from baseline to 12 months in FGF23 level.
Change from Baseline to 12 months in serum phosphate level
| Arm | Type | Description |
|---|---|---|
| Lanthanum carbonate + nicotinamide | EXPERIMENTAL | One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. |
| Lanthanum carbonate + nicotinamide placebo | PLACEBO_COMPARATOR | Two lanthanum carbonate 500 mg capsules by mouth with each meal (3000 mg) for 12 months. One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. |
| Lanthanum carbonate placebo and nicotinamide | ACTIVE_COMPARATOR | One nicotinamide 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months. |
| Lanthanum carbonate placebo and nicotinamide placebo | PLACEBO_COMPARATOR | One Placebo (for nicotinamide) 750 mg capsule by mouth twice daily (1500 mg) for 12 months. Two Placebo (for lanthanum carbonate) 500 mg capsules by mouth with each meal (3000 mg) for 12 months. |
| Name | Type | Description |
|---|---|---|
| Nicotinamide | DRUG | - |
| Lanthanum Carbonate | DRUG | - |
| Placebo (for Nicotinamide) | DRUG | Sugar pill manufactured to mimic Nicotinamide 750 mg capsule |
| Placebo (for lanthanum carbonate) | DRUG | Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule |
Inclusion Criteria: 1. Patients with estimated glomerular filtration rate (eGFR) 20-45 ml/min/1.73m2 2. Age 18-85 years 3. Serum phosphate ≥ 2.8 mg/dL 4. Platelet count ≥ 125,000/mm3 5. Able to provide consent 6. Able to travel to study visits 7. Able to eat at least two meals a day 8. In the opini...
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