cardiovascular disease in chronic kidney disease
Conditions
Interventions
All patients will receive standard care, including blood pressure management
with use of RAAS inhibitors, sodium restriction and lipid lowering drugs as
indicated. At baseline al the patients will s
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. phosphate binder therapy, antiarrhythmic agents or anticonvulsants). 2. Patients with albumin-to-creatinine ratio > 100 mg/mmol not receiving ACE-inhibitors or ARB. 3. Women, who are pregnant or breastfeeding. 4. Change in vitamin D dose 4 weeks prior to baseline. 5. History of parathyroidectomy. 6. Hyperparathyroidism (e.g. PTH levels >2.5 upper normal) 7. History of arrhythmia or seizures. 8. Patients who have bowel obstruction, or malabsorption. 9. Posttransplant patients. 10. Body mass index > 35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in C-terminal FGF-23 (Immutopics) in the highest dose of sevelamer compared to baseline for the entire cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Dose response relationship between C-terminal FGF-23 and sevelamer dose of the entire cohort. * Explorative variables: 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 proteinuria. | — |
Countries
Netherlands
Outcome results
None listed