Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helse Stavanger HF
• Collaborator: Rikshospitalet University Hospital
• Treatments: Alfacalcidol; Hydroxycholecalciferols; Sevelamer; Vitamin D

Criteria

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