Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.
- Registration Number
- NCT01231438
- Lead Sponsor
- Helse Stavanger HF
- Brief Summary
Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
- Renal failure stage 3B
- 25(OH)vitamin D level above 50 nmol/l
- Age over 18 years
- Written consent
Exclusion Criteria
- Major surgery during the previous 6 months
- Myocardial infarct during the previous 6 months
- Unstable heart failure
- Ongoing treatment for any malignancy
- History of frequent infections
- Pregnancy
- Ongoing treatment with steroids, lithium or biphosphonates
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Renvela Renvela Treatment for 2 weeks Etalpha Etalpha Vit D Treatment for 2 weeks
- Primary Outcome Measures
Name Time Method FGF23 serum level Change over 2 weeks of treatment
- Secondary Outcome Measures
Name Time Method Calcium serum level Change over 2 weeks of therapy Phosphate serum level Change over 2 weeks of therapy CTX-1 serum level Change over 2 weeks of therapy PINP serum level Change over 2 weeks of therapy PTH serum level Change over 2 weeks of therapy
Trial Locations
- Locations (2)
Stavanger University Hospital
🇳🇴Stavanger, Norway
Oslo Universitetssykehus Rikshospitalet
🇳🇴Oslo, Norway