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

November 8, 2012 updated by: Helse Stavanger HF

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, NO-0372
        • Oslo Universitetssykehus Rikshospitalet
      • Stavanger, Norway, NO-4011
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Renvela
Treatment for 2 weeks
Drug: Renvela
800mg t.i.d. over 2 weeks
Other Names:
  • Sevelamercarbonate
EXPERIMENTAL: Etalpha
Vit D Treatment for 2 weeks
Drug: Etalpha
0.25ug o.d. for 2 weeks
Other Names:
  • Alfakalsidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FGF23 serum level
Time Frame: Change over 2 weeks of treatment
Change over 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Calcium serum level
Time Frame: Change over 2 weeks of therapy
Change over 2 weeks of therapy
Phosphate serum level
Time Frame: Change over 2 weeks of therapy
Change over 2 weeks of therapy
CTX-1 serum level
Time Frame: Change over 2 weeks of therapy
Change over 2 weeks of therapy
PINP serum level
Time Frame: Change over 2 weeks of therapy
Change over 2 weeks of therapy
PTH serum level
Time Frame: Change over 2 weeks of therapy
Change over 2 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Stavanger HF

Collaborators

Rikshospitalet University Hospital

Investigators

  • Principal Investigator: Lasse Göransson, MD PhD, Helse Stavanger HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (ESTIMATE)

November 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUS2010GOLA01
  • 2010-020415-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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