Kidney Failure
Conditions
Keywords
Renal failure stage 3B
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.
Interventions
DRUGRenvela
800mg t.i.d. over 2 weeks
DRUGEtalpha
0.25ug o.d. for 2 weeks
Sponsors
Rikshospitalet University Hospital
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FGF23 serum level | Change over 2 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Calcium serum level | Change over 2 weeks of therapy |
Countries
Norway
Outcome results
None listed