ThE SoF-Trial (SoFT) - The Effect of Sevelamer on FGF23 Trial - A clinical trial assessing the quantitative effect of phosphate binding therapy on FGF23.

Vrije Universiteit Medical Center0 个研究点开始时间: 2013年10月4日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•1.Patients with stage II-IV CKD or with stage I CKD with an albumin-to-creatinine ratio in a first morning spot urine specimen of 100 mg/mmol, while on ACE-inhibition or on ARBs.
•2.Serum phosphate levels between 0.80-1.45 mmol/l.
•3.Not taking any phosphate binder therapy.
•4.Providing informed consent.
•Inclusion will be stratified according to stage CKD according to the National Kidney Foundation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1.Patients who, in the opinion of the study investigator may present a safety risk.
•2.Patients who are unlikely to adequately comply with the trial’s procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
•3.Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. phosphate binder therapy, antiarrhythmic agents or anticonvulsants).
•4.Patients with albumin-to-creatinine ratio > 100 mg/mmol not receiving ACE-inhibitors or ARB.
•5.Patients with LDL-cholesterol >2.5 not receiving statin therapy.
•6.Patients taking other experimental (i.e., non marketed) therapies.
•7.Women, who are pregnant or breastfeeding.
•8.Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational product.
•9.Change in vitamin D dose 4 weeks prior to baseline.
•10.History of hyperparathyroidism or parathyroidectomy.
•11.History of arrhythmia or seizures.
•12.Patients who have bowel obstruction, or malabsorption.
•13.Posttransplant patients.
•14.Allergy or intolerance for study medication.
•15.Body mass index > 35
•16.History of ADPKD

发起方

Vrije Universiteit Medical Center