Effects of Sevelamer Carbonate in Patients With CKD and Proteinuria: The ANSWER Randomized Trial

Perticucci, Elena; Bellasi, Antonio; Cozzolino, Mario; Kohan, Donald E.; Ruggenenti, Piero; Remuzzi, Giuseppe; Perico, Norberto; Ruggiero, Barbara; Trillini, Matias; Aparicio, Carolina; Prandini, Silvia; Lecchi, V.; Cugini, Daniela; Zoccali, Carmine; Mallamaci, Francesca; Parlongo, Giovanna; Panuccio, Vincenzo; Caridi, Gianluca; Tripepi, Rocco; Rubis, Nadia; Diadei, Olimpia; Villa, Davide; Carminati, Sergio; Martinetti, Davide; Giuliano, Giovanni; Perna, Annalisa; Peraro, Francesco; Celeste, Angela; Gaspari, Flavio; Carrara, Fabiola; Ferrari, Silvia; Stucchi, Nadia; Cannatà, Antonio; Mazzaferro, Sandro; Tartaglione, Lida; Rotondi, Silverio; Fassino, Valeria; Boccardo, Paola; Peracchi, S.

doi:10.1053/j.ajkd.2019.01.029

Cited by 20 publications

(16 citation statements)

References 37 publications

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“…Indeed, the antiproteinuric effect of both ACE-I and low protein diet seems to vanish as serum phosphate levels increase [3,13]. However, in contrast with these observations, 3-mon administration of Sevelamer, a non-calcium containing phosphate binder, failed to reduce proteinuria in a recently published cross-over randomized controlled study (RCT) [23] of 53 middle age (mean age 55 + 17), normophosphatemic (mean serum phosphate: 3.8 + 0.6) stage 3 CKD patients (mean GFR 49 + 23 mL/min/1.73 m 2 ) with optimal renin-agiotensin-aldosterone (RAAS) system blockage [23].…”

Section: Discussionmentioning

confidence: 99%

“…Although it is possible that phosphate is not causally related to clinical outcome, these RCTs recruited CKD patients with normophosphatemia and no information on phosphate balance has been reported. Administration of phosphate binders in these subjects had minimal or no effects on serum levels but a larger effect on urinary levels of phosphorous [23,24,25], suggesting that renal excretion is modulated according to phosphate balance rather than serum levels [6] and that subjects with normophosphatemia maybe exposed to positive as well as negative phosphate balances [6]. Indeed, overt hyperphosphatemia develops only if the number of residual and functional nephrons cannot compensate for the daily phosphate intake [6].…”

Section: Discussionmentioning

confidence: 99%

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Fractional Excretion of Phosphate (FeP) Is Associated with End-Stage Renal Disease Patients with CKD 3b and 5

Bellasi

Micco²,

Russo

et al. 2019

JCM

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Background: The perturbation of phosphate homeostasis portends unfavorable outcomes in chronic kidney disease (CKD). However, the absence of randomized clinical trials (RCT) fuels the discussion of whether phosphate or some other phosphorous-related factor(s) such as fibroblast growth factor 23 (FGF-23) mediates the cardiovascular and systemic toxicity. We herein test whether the fractional excretion of phosphate (FeP) as a marker of renal stress to excrete phosphorous predicts unfavorable outcomes in CKD patients. Methods: Retrospective, cross-sectional observational study. For current analysis, an historical cohort of 407 records of CKD stage 3b-5 patients attending between January 2010 and October 2015 at the Nephrology Unit of Solofra (AV), Italy were utilized. Demographic, clinical, laboratory, and outcome data were identified through the subjects’ medical records. We tested whether quartiles of FeP are associated with the risk of CKD progression or all causes of death. Parametric as well as non-parametric tests, linear and logistic regression, as well as survival analysis were utilized. Results: Overall, we investigated middle-age (mean 66.0, standard deviation 12.3 years) men and women (male 43%) with CKD stage 3b to 5 (creatinine clearance 32.0 (13.3) mL/min). Older age, lower diastolic blood pressure, poor renal function, as well as higher serum phosphate were associated with FeP. Patients with higher FeP were at an increased risk of starting dialysis or dying (hazard ratio 2.40; 95% confidence interval (1.44, 3.99)). Notably, when the two endpoints were analyzed separately, FeP was associated with renal but not all-cause survival. Conclusion: FeP is associated with ESRD, but not all-cause mortality risk in a large cohort of moderate to advanced CKD patients. Future efforts are required to validate FeP as a marker of nephron stress and risk factor for CKD progression in this high-risk population.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Fractional Excretion of Phosphate (FeP) Is Associated with End-Stage Renal Disease Patients with CKD 3b and 5

Bellasi

Micco²,

Russo

et al. 2019

JCM

Self Cite

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“…10 Other trials have found similar results, with phosphate binders largely affecting urine phosphate excretion, but not serum levels of phosphate or its regulatory hormones. [11][12][13] In a small single-center study of ferric citrate in CKD G4-G5, random assignment to ferric citrate resulted in stabilization of FGF-23 levels. 14 The major challenge in phosphate-binder trials in CKD G3-G5 is that all were designed for surrogate outcomes and not patient-centered or clinical outcomes.…”

Section: Overall Evidence For Phosphate-binding Therapy Ckd G3-g5mentioning

confidence: 99%

“…The Hi-Lo trial will compare phosphate targets of <5.5 to >6.5 mg/dL on a composite of mortality and In addition to lowering serum phosphate levels, sevelamer-based binders also lower serum cholesterol levels and reduce levels of inflammatory markers. 11,24 Lanthanum carbonate is a minimally absorbed metal cation binder approved under the trade name Fosrenol (Shire Pharmaceuticals) in 2004. Efficacy for lanthanum carbonate appears similar to other binders.…”

Section: Ckd G5dmentioning

confidence: 99%

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State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective

Scialla

Kendrick

Uribarri

et al. 2021

American Journal of Kidney Diseases

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Phosphate binders are among the most common medications prescribed to patients with kidney failure receiving dialysis and are often used in advanced chronic kidney disease (CKD). In patients with CKD glomerular filtration rate category 3a (G3a) or worse, including those with kidney failure who are receiving dialysis, clinical practice guidelines suggest "lowering elevated phosphate levels towards the normal range" with possible strategies including dietary phosphate restriction or use of binders. Additionally, guidelines suggest restricting the use of oral elemental calcium often contained in phosphate binders. Nutrition guidelines in CKD suggest <800-1,000 mg of calcium daily, whereas CKD bone and mineral disorder guidelines do not provide clear targets, but <1,500 mg in maintenance dialysis patients has been previously recommended. Many different classes of phosphate binders are now available and clinical trials have not definitively demonstrated the superiority of any class of phosphate binders over another with regard to clinical outcomes. Use of phosphate binders contributes substantially to patients' pill burden and out-of-pocket costs, and many have side effects. This has led to uncertainty regarding the use and best choice of phosphate binders for patients with CKD or kidney failure. In this controversies perspective, we discuss the evidence base around binder use in CKD and kidney failure with a focus on comparisons of available binders.Complete author and article information provided before references.

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Effectiveness of fibroblast growth factor 23 lowering modalities in chronic kidney disease: a systematic review and meta-analysis

et al. 2021

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Effects of Sevelamer Carbonate in Patients With CKD and Proteinuria: The ANSWER Randomized Trial

Cited by 20 publications

References 37 publications

Fractional Excretion of Phosphate (FeP) Is Associated with End-Stage Renal Disease Patients with CKD 3b and 5

Fractional Excretion of Phosphate (FeP) Is Associated with End-Stage Renal Disease Patients with CKD 3b and 5

State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective

Effectiveness of fibroblast growth factor 23 lowering modalities in chronic kidney disease: a systematic review and meta-analysis

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