Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease? - Effects of phosphate binding in stage 3 chronic kidney disease
Phase 1
- Conditions
- Chronic kidney disease stage 3 (eGFR 30-59 ml/min/1.73m2)MedDRA version: 9.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease
- Registration Number
- EUCTR2008-003727-23-GB
- Lead Sponsor
- niversity Hospital Birmingham NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Chronic kidney disease stage 3 (eGFR 30-59 ml/min/1.73m2)
Age 18-80 years
Well controlled blood pressure (<140/90 mmHg)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Diabetes mellitus
Bowel obstruction
Dysphagia/swallowing disorders
Severe gastrointestinal motility disorders
Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue
Hypophosphataemia (serum phosphate <0.8 mmol/l)
Uncontrolled hyperphosphataemia (serum phosphate >1.8 mmol/L)
Uncontrolled secondary hyperparathyroidism (PTH >80 pg/ml)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method