Table 1.
Study | Inclusion Criteria | n | Intervention | Control | Mean Age (yrs) | Primary Outcome | Baseline Kidney Function | Mean Baseline Serum Phosphate (mg/dl) | Follow- Up (mos) | Industry-sponsored Funding |
---|---|---|---|---|---|---|---|---|---|---|
Russo 200740 | CKD Stage 3–5; without cardiovascular disease | 90 | Low phosphate diet versus sevelamer | Calcium carbonate | 54 | Coronary artery calcification | eGFR 26.2–33.4 ml/min per 1.73 m2 | 3.9–4.6 | 24 | Nil |
Block 2012 (PNT)22 | eGFR 20–40ml/m in per 1.73m2; serum phosphate >3.5 mg/dl, <6.0 mg/dl | 148 | Lanthanum carbonate versus calcium versus sevelamer | Placebo | 68 | Serum phosphate | eGFR 32 ml/min per 1.73 m2 | 4.2 | 9 | Genzyme, Davita, Fresenius, Novartis |
Di Iorio 201234 | CKD Stage 3–4 | 239 | Sevelamer | Calcium carbonate | 57.9 | All-cause Mortality | CrCl 32.7 ml/min | 4.8 | 36 | Nil |
Chue 2013 (CRIB- PHOS)24 | CKD Stage 3; serum phosphate 2.5– 5.6 mg/dl | 120 | Sevelamer carbonate | Placebo | 55 | Left ventricular mass (MRI) | eGFR 50 ml/min per 1.73 m2 | 3.2 | 10 | Genzyme |
Isakova 201335 | CKD Stage 3–4; serum phosphate 2.5– 4.6 mg/dl | 39 | Low phosphate diet (900 mg)/placebo versus normal diet/lanthanum versus low phosphate diet/lanthanum | Placebo/normal diet | 55.4 | Serum FGF23 | eGFR 37.8 ml/min per 1.73 m2 | 3.6 | 3 | Shire |
Seifert 201323 | CKD Stage 3 | 38 | Lanthanum carbonate | Placebo | 61.5 | Serum phosphate | CrCl 47 ml/min 1.73 m2 | 3.4 | 12 | Shire |
Soriano 201341 | CKD Stage 4–5; serum phosphate > 4 mg/dl | 32 | Lanthanum, carbonate | Calcium carbonate | 60.4 | Serum FGF23 | eGFR 16.5 ml/min per 1.73 m2 | 4.95 | 4 | Nil |
Lemos 201336 | CKD Stage 3–5 | 117 | Sevelamer hydrochloride versus rosuvastatin | Standard of care | 56.4 | Coronary artery calcification | eGFR 35.8 ml/min per 1.73 m2 | 3.8 | 24 | Genzyme |
Yokoyama 201442 | CKD Stage 3–5; serum phosphate ≥5.0-<8.0 mg/dl | 90 | Ferric citrate | Placebo | 65.1 | Serum phosphate | eGFR 9.21 ml/min per 1.73 m2 | 5.63 | 3 | Japan Tobacco |
Ureña- Torres 201437 | CKD Stage 3; serum phosphate 0.808–1.55 mmol/L) | 35 | Lanthanum carbonate | Placebo | 67 | Serum intact FGF23 | eGFR 44.4 ml/min per 1.73 m2 | NR | 3 | Shire |
Block 201543 | CKD Stage 3–5; serum phosphate >4.0– 6.0 mg/dl | 149 | Ferric citrate | Placebo | 65 | Serum phosphate and transferrin saturations | eGFR 24.3 ml/min per 1.73 m2 | 4.6 | 3 | Keryx Biopharmaceuticals |
Akizawa 201646 | CKD Stage 3–5; serum phosphate >4.6 mg/dl | 163 | Bixalomer | Placebo | 64.2 | Serum phosphate | eGFR 10.1 ml/min per 1.73 m2 | 5.28 | 3 | Astellas |
Fishbane 201747 | CKD Stage 3–5; serum phosphate >3.5 mg/dl | 232 | Ferric citrate | Placebo | 65.4 | Hemoglobin | eGFR 28.6 ml/min per 1.73 m2 | 4.2 | 4 | Keryx Biopharmaceuticals |
Liabeuf 201738 | CKD Stage 3–4b; serum phosphate >3.1 mg/dl | 78 | Sevelamer carbonate | Placebo | 63 | Serum c- terminal FGF23 | eGFR 27 ml/min per 1.73 m2 | 3.7 | 3 | Sanofi/Genzyme |
Kovesdy 201825 | CKD Stage 3–4; serum phosphate >4.6 mg/dl | 120 | Lanthanum carbonate | Calcium acetate | 66.1 | Biochemical outcomes (serum phosphate, calcium, PTH) | eGFR 32 ml/min per 1.73 m2 | 3.8 | 12 | Shire |
Riccio 201844 | CKD Stage 3–5 | 69 | Sevelamer hydrochloride | Placebo | Between 54.7–56.9 | P-cresol levels | eGFR 38.3–39.1 ml/min per 1.73 m2 |
4.3–4.4 | 3 | Nil |
Block 201945 | eGFR ≤20 ml/min per 1.73 m2 | 203 | Ferric citrate | Standard of care | Between 61.1–63.1 | Biochemical outcomes (serum phosphate, FGF23, | eGFR between 14.2–14.5 ml/min per 1.73 m2 | 4.4–4.5 | 9 | Keryx Biopharmaceuticals |
PTH) and hemoglobin | ||||||||||
Ix 201926 | eGFR 20–40 ml/min per 1.73m2; serum phosphate ≥2.8 mg/dl | 205 | Nicotinamide versus lanthanum carbonate | Placebo | 69 | Serum phosphate and FGF23 | eGFR 32 ml/min per 1.73 m2 | 3.7 | 12 | Medications provided by Shire and Endurance |
Ruggiero 201939 | eGFR >15ml/min per 1.73m2; serum phosphate 2.5–5.5 mg/dl |
53 | Sevelamer carbonate | Standard of care | 55 | 24-hour proteinuria | eGFR 49 ml/min per 1.73 m2 | 3.8 | 3 | Sanofi |
Toussaint 202027 | CKD Stage 3–4b; serum phosphate ≥ 3.10 mg/dl | 278 | Lanthanum carbonate | Placebo | 63.1 | Carotid- femoral PWV | eGFR 21.8 ml/min per 1.73 m2 | 3.87 | 24 | Shire |
CrCl, creatinine clearance; MRI, magnetic resonance imaging.