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

Kidney Failure Clinical Trial

Official title:

An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231438
• Other study ID #: SUS2010GOLA01
• Secondary ID: 2010-020415-36
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2010
• Last updated: November 8, 2012
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Renvela
800mg t.i.d. over 2 weeks
• Etalpha
0.25ug o.d. for 2 weeks

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo
Norway	Stavanger University Hospital	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bleskestad IH, Bergrem H, Hartmann A, Godang K, Gøransson LG. Fibroblast growth factor 23 and parathyroid hormone after treatment with active vitamin D and sevelamer carbonate in patients with chronic kidney disease stage 3b, a randomized crossover trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FGF23 serum level		Change over 2 weeks of treatment	No
Secondary	Calcium serum level		Change over 2 weeks of therapy	No
Secondary	Phosphate serum level		Change over 2 weeks of therapy	No
Secondary	CTX-1 serum level		Change over 2 weeks of therapy	No
Secondary	PINP serum level		Change over 2 weeks of therapy	No
Secondary	PTH serum level		Change over 2 weeks of therapy	No