ThE SoF-Trial (SOFT) - The Effect of Sevelamer on FGF23 Trial - A clinical trial assessing the effect of a phosphate restricted diet and phosphatebinding therapy on the protein FGF23.

Conditions: cardiovascular disease in chronic kidney disease
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-002373-22-NL

Lead Sponsor: Vrije Universiteit Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the feasibility to induce an effective, predictable and sustained decrease in FGF23 level in CKD stage I-IV patients, without inducing hypophosphatemia using a stepped treatment regimen aiming at restricting phosphate uptake. ;Secondary Objective: Non applicable;Primary end point(s): 1)To demonstrate the absolute (reference unit per ml) and percentage change in C-terminal FGF-23 (Immutopics) in the highest tolerable dose of sevelamer compared to baseline for each stage of CKD. <br>2)To demonstrate the dose response relationship between C-terminal FGF-23 and sevelamer dose of the entire cohort. <br>;Timepoint(s) of evaluation of this end point: After the study is completed, so after 18 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following explorative variables will be assessed: plasma levels of creatinine, phosphate, albumin, calcium, 25(OH)2D and 1,25(OH)2D3 and PTH. Urine: 24 hours phosphate excretion, TmP/GFR and albuminuria. ;Timepoint(s) of evaluation of this end point: See E.5.1.1.