SoFT - Sevelamer on FGF23 Trial - A clinical trial assessing the quantitative effect of phosphate binding therapy on FGF23.
- Conditions
- cardiovascular disease in chronic kidney disease1001329610038430
- Registration Number
- NL-OMON41487
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in C-terminal FGF-23 (Immutopics) in the highest dose of sevelamer<br /><br>compared to baseline for the entire cohort.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Dose response relationship between C-terminal FGF-23 and sevelamer dose of<br /><br>the entire cohort.<br /><br>* Explorative variables: plasma levels of creatinine, phosphate, albumin,<br /><br>calcium, 25(OH)2D and 1,25(OH)2D3 and PTH. Urine: 24 hours phosphate<br /><br>excretion, TmP/GFR and proteinuria. </p><br>