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

Helse Stavanger HF

Status and phase: Completed; Phase 2

Conditions: Kidney Failure

Treatments: Drug: Renvela; Drug: Etalpha

Study type: Interventional

Funder types: Other

Identifiers

NCT01231438

SUS2010GOLA01

2010-020415-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Renvela

Experimental group

Description:

Treatment for 2 weeks

Treatment:

Drug: Renvela

Etalpha

Experimental group

Description:

Vit D Treatment for 2 weeks

Treatment:

Drug: Etalpha