An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other...
HyperphosphatemiaInflammation1 moreThe purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
Kidney DiseasesRenal InsufficiencyThis is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.
Hyperphosphatemia in Children With Chronic Kidney Disease
Hyperphosphatemia"Chronic Kidney Disease-Mineral and Bone Disorder " is a systemic disorder of mineral and bone metabolism, due to chronic kidney disease that is manifested by either one or a combination of the following : Abnormalities of calcium, phosphate, parathyroid hormone or vitamin D metabolism Vascular and/or soft tissue calcification. Abnormalities in bone turnover, metabolism, volume, linear growth or strength. According to glomerular filtration rate , Kidney Disease Improving Global Outcomesclassify chronic kidney disease into 5 stages,stage 5 also known as End Stage Renal disease is defined as glomerular filtration rate less than 15 ml/Min/1.73 m2, or the need for renal replacement therapy for survival The kidney plays a major role in phosphate homoeostasis. The kidneys excrete the total net amount of absorbed phosphate.Under normal physiological condition phosphate is freely filtered through the glomerulus. The majority (85-90%) of filtered phosphate undergoes tubular reabsorption primarily in proximal tubules. Progressive renal insufficiency leads to hyperphosphatemia, hypocalcemia, and secondary hyperparathyroidism . Hyperphosphatemia known as hidden killer in chronic kidney disease defined as an abnormally high serum phosphate concentration of >1.46 mmol/L (4.5 mg/dL). Its long term complications are renal osteodystrophy, hyperparathyroidism, and increased cardiovascular calcification leading to increased mortality and morbidity . High serum phosphate can interact with calcium to precipitate calcium phosphate salts in non-skeletal tissues Calcification generally occurs in the blood vessels, heart valves, myocardium, and other soft tissues . Cardiovascular calcification is probably the main reason for the high prevalence of cardiovascular diseases in chronic kidney disease patients Studies have shown that hyperphosphatemia is associated with increased vascular stiffening and arterial and valvular calcification This is postulated to be caused by elevated serum phosphorus promoting the transformation of vascular smooth muscle cells into an osteoblast phenotype that can mineralize These vascular calcification also lead to left ventricular hypertrophy by decreasing vascular compliance . Poor control of mineral metabolism also has been associated with functional and structural cardiac abnormalities Efforts to reduce morbidity and mortality associated with Chronic Kidney Disease-Mineral and Bone Disorder are therefore primarily directed at controlling hyperphosphatemia via diet, phosphorus binders, and dialysis Dialysis alone is inadequate in assisting hemodialysis patients to obtain and maintain normal serum phosphate levels . So, other methods of achieving prescribed levels of serum phosphate in hemodialysis patients include the use of phosphate binders and phosphorus dietary restrictions.: Phosphate binders have been approved by the Federal Drug Administration (FDA) for patients treated with maintenance dialysis, and calcium-containing salts are used worldwide not only for the control of hyperphosphatemia but also as a source of supplemental calcium. Several calcium salts are commercially available, including calcium carbonate, calcium acetate, and calcium citrate Sevelamer hydrochloride is a recently developed phosphate binder, which is a quaternary amine anion exchanger without calcium or aluminum. Sevelamer is effective in controlling hyperphosphatemia without increasing the calcium load in chronic hemodialysis patients In addition to its effects on serum phosphorous levels, sevelamer has been shown to decrease total serum cholesterol and low-density lipoprotein cholesterol and to increase high-density lipoprotein levels . These effects may offer additional benefits in reducing cardiovascular complications in patients with end-stage renal disease. Controlling abnormal laboratory parameters such as calcium ,phosphate and parathyroid hormone as well as preventing the progression of extraskeletal calcification is considered a major component for prevention of the bone disease and other related morbidities and hopefully mortality in chronic kidney disease patients
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
End Stage Renal DiseaseHyperphosphatemiaThe purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia...
Renal InsufficiencyChronic3 moreThe purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene...
HyperphosphatemiaThe aim of the study is: To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses; To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple administration.
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate...
HyperphosphatemiaMalnutritionAim: Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients. Inclusion criteria: The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0 mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion. Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions. Intervention protocol: At baseline, the investigators collect demography and pre-test KAP questionnaires among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview and record their answers. Dietary Phosphorus Education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly. The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and third month were monthly education sessions, each 20 to 30 minutes. There are total 6 sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. Investigator collect post-test KAP questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. If subjects are illiterate then investigators interview subjects and record. This is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.
The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients
HyperphosphatemiaHyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.
Fosrenol Post-marketing Surveillance in Japan
HyperphosphatemiaKidney DiseaseThis study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol. The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months. The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients
Chronic Renal Failure Patients With Hyperphosphataemia Receiving HemodialysisThe purpose of this survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.