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

NCT ID: NCT01231438

Last Updated: 2012-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Failure

Keywords

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Renal failure stage 3B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renvela

Treatment for 2 weeks

Group Type EXPERIMENTAL

Renvela

Intervention Type DRUG

800mg t.i.d. over 2 weeks

Etalpha

Vit D Treatment for 2 weeks

Group Type EXPERIMENTAL

Etalpha

Intervention Type DRUG

0.25ug o.d. for 2 weeks

Interventions

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Renvela

800mg t.i.d. over 2 weeks

Intervention Type DRUG

Etalpha

0.25ug o.d. for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Sevelamercarbonate Alfakalsidol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rikshospitalet University Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lasse Göransson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helse Stavanger HF

Locations

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Oslo Universitetssykehus Rikshospitalet

Oslo, , Norway

Site Status

Stavanger University Hospital

Stavanger, , Norway

Site Status

Countries

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Norway

References

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Bleskestad IH, Bergrem H, Hartmann A, Godang K, Goransson 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. BMC Nephrol. 2012 Jun 28;13:49. doi: 10.1186/1471-2369-13-49.

Reference Type RESULT
PMID: 22742720 (View on PubMed)

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Other Identifiers

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2010-020415-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SUS2010GOLA01

Identifier Type: -

Identifier Source: org_study_id