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Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Phase III Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate [FOSRENOL®]

A Multicenter Study on the Effects of Lanthanum Carbonate (FOSRENOL®) and Calcium Carbonate

Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Phase III Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate [FOSRENOL®]: A New Phosphate Binder for the Treatment of Hyperphosphatemia.

Joy MS, Finn WF. LAM-302 Study Group, American Journal of Kidney Diseases, 2003;42(1):96-107.

Methods/Design

  • Randomized, double-blind, placebo-controlled, parallel-group study
  • 14 sites
  • 1-3 week washout phase to raise serum phosphorus levels to >5.9 mg/dL
  • 6-week titration phase to achieve and maintain serum phosphorus ≤5.9 mg/dL
  • 4-week, double-blind, placebo-controlled maintenance phase

Patients

  • Hemodialysis patients =18 years old
  • 163 enrolled, 126 titrated
  • 94 in placebo-controlled phase
  • Mean age 60 ±13.4 years
  • 66% males

Medications

  • Placebo
  • FOSRENOL® 375; 750; 1,500; 2,250; or 3,000 mg/day

Results

At study endpoint, serum phosphorus levels, Ca x P products, and serum PTH levels were significantly reduced in the FOSRENOL® group compared with placebo.

Adverse Events

The incidence of drug-related adverse events was similar between the FOSRENOL® group and placebo group during the placebo-controlled phase. Diarrhea and nausea occurred in a similar proportion of patients in both groups. Dialysis graft occlusion and vomiting occurred more frequently in the FOSRENOL® group.

Conclusions

FOSRENOL® is effective and well tolerated for the treatment of hyperphosphatemia in patients with CKD Stage 5.

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A Multicenter Study on the Effects of Lanthanum Carbonate (FOSRENOL®) and Calcium Carbonate on Renal Bone Disease in Dialysis Patients.

D’Haese PC, Spasovski GB, Sikole A, et al. Kidney International. 2003;63(85):S73-S78.

Methods/Design

  • Randomized, 1-year, open-label, comparative-controlled, parallel-group renal osteodystrophy (ROD) study
  • 18 centers in 12 countries
  • Bone biopsies were taken at baseline and after 1 year of treatment
  • Patients were randomized to FOSRENOL® or calcium carbonate and titrated

Patients

  • Hemodialysis patients =18 years old
  • 98 randomized, 68 completed, 63 evaluable paired bone biopsies (33 in lanthanum carbonate group, 30 in calcium group)
  • Mean age 55 ±14.3 years
  • 60% males

Medications

  • FOSRENOL® up to 3,750 mg/day
  • Median dose 1,250 mg/day
  • Calcium carbonate (CC) up to 9,000 mg/day
  • Median dose 2,000 mg/day

Results

Adynamic bone disease occurred in 4% of patients receiving FOSRENOL® vs 26% in the calcium group. Most lanthanum-treated patients with adynamic bone or osteomalacia at baseline (71%) evolved toward a normalization of bone turnover, compared with 42% of patients that received calcium.

Adverse Events

Adverse events were similar between the FOSRENOL® and calcium groups, with 96% of patients reporting at least 1 treatment-emergent adverse event. Gastrointestinal adverse events were most common, and were reported in 53% of FOSRENOL®-treated and 49% of calcium-treated patients.

Conclusions

Lanthanum carbonate is a poorly absorbed, well-tolerated and efficient phosphate binder. LC-treated dialysis patients show almost no evolution toward low bone turnover over 1 year (unlike CC-treated patients), nor do they experience any aluminum-like effects on bone.

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FOS-00024 07/08