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OpenTrials
Completed

NCT Number: NCT01231438

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

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.

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oslo Universitetssykehus Rikshospitalet, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renvela

Drug

800mg t.i.d. over 2 weeks

Other names: Sevelamercarbonate

Etalpha

Drug

0.25ug o.d. for 2 weeks

Other names: Alfakalsidol

Primary outcomes

  1. FGF23 serum level

    Time frame: Change over 2 weeks of treatment

Secondary outcomes

  1. Calcium serum level

    Time frame: Change over 2 weeks of therapy

  2. Phosphate serum level

    Time frame: Change over 2 weeks of therapy

  3. CTX-1 serum level

    Time frame: Change over 2 weeks of therapy

  4. PINP serum level

    Time frame: Change over 2 weeks of therapy

  5. PTH serum level

    Time frame: Change over 2 weeks of therapy

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Rikshospitalet University Hospital

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2010
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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