A Two-Arm, Open-Label, Standard of Care Control Evaluation of Ferric Citrate for the Transition From Chronic Kidney Disease Stage 4/5 to Chronic Kidney Stage 5D

It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.

开始日期2015-03-01

申办/合作机构

Denver Nephrologists PC

[+1]

NCT01475760 / CompletedN/A

A Multi-Center, Open Label Study to Evaluate Chitosan Chewing Gum in Patients With Chronic Kidney Disease

The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in reducing serum phosphorus in subjects with chronic kidney disease.

开始日期2011-11-01

申办/合作机构

Denver Nephrologists PC

[+1]

NCT01319578 / CompletedN/A

A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum

The specific purpose of this study is to describe the characteristics of the K2CG chewing gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing in relation to a meal, and dose of K2CG chewing gum.

开始日期2011-07-01

申办/合作机构

Denver Nephrologists PC

[+1]

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Clinical Nephrology

Prevalence and clinical consequences of elevated Ca × P product in hemodialysis patients

作者: Block, G. A.

A review, with ∼29 referencesControl of serum phosphorus (P) levels is a central goal of managing patients with chronic renal failure (CRF).Hyperphosphatemia develops invariably with kidney failure, and inadequate control of serum P leads to an elevated calcium-phosphorus (Ca × P) product.Further contributing to an elevated Ca × P product is the fact that hemodialysis patients are generally in a net pos. calcium balance-dietary intake of calcium, ingestion of calcium-based phosphate binders, calcium absorption from dialyzate, and abnormalities in bone buffering and turnover all contribute to the calcium burden in hemodialysis patients.In addition, treatment with calcitriol to manage secondary hyperparathyroidism increases intestinal absorption of both calcium and P.These abnormalities in divalent ion metabolism can result in a number of harmful conditions in CRF patients, including vascular calcification, cardiovascular disease, calciphylaxis, and death.We are now beginning to realize that our current therapeutic approaches to CRF management may not only be ineffective in controlling P and Ca × P product, but may actually contribute to serious calcific and cardiovascular hazards in these patients.Elevated P and Ca × P product are both significant predictors of cardiovascular mortality in hemodialysis patients.These effects are observed at P and Ca × P product levels that were considered safe until recently.Based on current national studies, we now recommend that serum P levels and Ca × P product of patients with CRF be maintained between 3.0-5.0 mg/dL and less than 55 mg²/dL², resp.Achieving these more rigorous treatment goals will require a shift in our therapeutic management strategies to incorporate aggressive use of calcium-free phosphate binders and, when necessary, use of less calcemic vitamin D analogs.

Nephron Clinical Practice4区 · 医学

Effect of Salivary Phosphate-Binding Chewing Gum on Serum Phosphate in Chronic Kidney Disease

4区 · 医学

Article

作者: Persky, Martha S. ; Sharma, Amit ; Comelli, Maria C. ; Shamblin, Beth M. ; Pergola, Pablo ; Smits, Gerard ; Singh, Bhupinder ; Block, Geoffrey A. ; Baltazar, Marissa F.

Background/Aims: Serum phosphate (P) has been linked to adverse events in patients with chronic kidney disease. Salivary phosphate (Psal) has been proposed as a potential target of therapy with a chitosan-containing chewing gum. Methods: We conducted several pilot studies to characterize Psal and its relationship with kidney function and subsequently conducted two clinical efficacy studies: a double-blind placebo-controlled trial in patients with end-stage renal disease (ESRD) and an open-label trial in those with stage 3-4 CKD. Results: Pilot studies demonstrated no relationship between the level of kidney function and Psal. Mean Psal was approximately 6.46 mmol/l across the entire spectrum of kidney function. Passive saliva collection demonstrated higher Psal concentration as compared to active collection. There was no evidence of diurnal variation in Psal. Twice daily 20 mg chitosan gum over 4 weeks reduced serum P by 0.065 mmol/l in the double-blind, placebo-controlled trial in ESRD (p = NS vs. placebo). In an open-label extension in these subjects, 40 mg chitosan gum three times daily reduced serum P by 0.065 mmol/l (p = 0.03 vs. end of washout). In a 2-week open-label trial in patients with CKD not on dialysis, 20 mg chitosan gum given three times daily reduced serum P by 0.05 mmol/l (p = 0.003 vs. day 1). Neither trial demonstrated any significant change in Psal with chitosan gum. Conclusions: Psal concentration is approximately 4-5 times that of serum P and is not related to glomerular filtration rate. Chitosan chewing gum resulted in a reduction of serum P by approximately 0.05-0.065 mmol/l but had no effect on Psal concentration.

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